Total 17 Quality Assurance / Control job vacancies in Highland Town Ctr

Duties & Responsibilities:

• Oversee and guide the Quality team to ensure effective quality control across the entire warehouse department.
• Collaborate with the Warehouse Manager to review and refine work instructions, ensuring clear and efficient operational procedures.
• Plan and conduct education and training programs to enhance the skills and knowledge of warehouse staff.
• Identify challenges in warehouse operations, analyze root causes, and implement solutions to improve quality and organizational efficiency.
• Develop and implement Kaizen (continuous improvement) strategies to enhance processes within the warehouse department.
• Plan and execute Internal Quality Assurance activities across all warehouses to maintain high-quality standards.
• Support the warehouse department in meeting and exceeding customer quality expectations.
• Manage the tasks and attendance of Quality team members, ensuring efficient and productive operations.
• Foster collaboration with managers and staff across Sankyu and other warehouses to optimize organizational performance.

Requirements:

• Diploma / Degree in Engineering and QMS related field with min 2 years of relevant experience
• Team player, good interpersonal and communication skills, able to work independently
• Good knowledge in ISO related management systems
• Candidate must possess at least Professional Certificate/NiTEC, Diploma/Advanced/Higher/Graduate Diploma, Bachelor's Degree/Post Graduate Diploma/Professional Degree in Engineering (Bioengineering/Biomedical), Engineering (Environmental/Health/Safety), Engineering (Mechanical), Engineering (Mechatronic/Electromechanical), Logistic/Transportation or equivalent.
• Working location: Tuas (**Shuttle service is provided from/to Tuas West Road MRT**)

A world empowered by autonomy. We build robotic vehicles to improve logistics safety, forge a greener Earth, and enhance human lives.

We are a closely-knit team aspiring to change the world through disruptive technology. We are innovators. We are tinkerers. We are problem-solvers. And we have a fair amount of magic dust up our sleeves. We have a plan for fleet-level deployment of autonomous vehicles, and we are looking for the best-of-the-best to join us in making this a reality.

About Venti Technologies

Based in the U.S. and Asia, Venti Technologies is the leader in safe-speed autonomous logistics systems, developing the future of goods transportation. Using rigorous mathematics, deep learning, and theoretically-grounded algorithms, Venti has a proprietary collection of autonomy technologies including a suite of powerful logistics algorithms. Venti’s proven value proposition of saving costs, increasing vehicle utilization, and improving safety is recognized by customers and driving growth. Launched in 2018, Venti brings together an unsurpassed team internationally. The company has autonomous systems deployed in Asia for industrial and logistics sites and a growing pipeline. Venti has offices in Cambridge (Massachusetts, USA), Suzhou (China), and Singapore – our Asian headquarters.

Position overview

We are seeking a highly skilled and motivated Senior Software Engineer to join our planning and control team. As part of this team, you will work on cutting-edge research and development of planning algorithms that enable autonomous systems to navigate complex environments safely and efficiently. This is an exciting opportunity for individuals who are passionate about advancing the field of autonomy and robotics. You will play a key role in the design, development, and optimization of behavior and motion planning systems while collaborating closely with cross-functional teams.

Role responsibilities

• Improve the existing software architecture and design the right software architecture for new components
• Design and develop clean, fast, reliable code
• Implement advanced features for autonomous vehicles
• Uphold code quality continuous integration, automated testing, and code reviews
• Drive software engineering best practices and processes
• Create technical design documents
• Mentor other software engineers

Required experience

• Bachelor's or Master's degree in Computer Science, Robotics, or related fields
• 5+ years experience writing production-quality code in modern C++
• Understanding of behavior planning, decision-making frameworks (e.g., finite state machines, behavior trees), or related AI techniques.
• Experience with Motion Planning algorithms, such as RRT, RRT*, and other graph-search based algorithms
• Experience developing in a Linux environment
• Strong organization and communication skills
• Flexible problem-solver
• Bonus experience
• Experience with ROS or other similar middleware
• Experience with real world safety critical applications
• Experience deploying software tools and/or metrics

Salary is commensurate with experience. We also offer world-class benefits, fantastic culture, flexible working arrangements, and a great international working environment. Come and join us!

Duties & Responsibilities

• Coordinate with Engineering, Construction, Procurement and Project groups to review the scope of work in terms of deliverables to be submitted to the client, to finalize schedules to be met, and utilize resources required as percontract.
• Perform schedule monitoring and updating of project schedule, preparation of periodic Progress Reports with commitments & forecasts. Propose corrective actions and follow-up.
• Prepare various Weekly/Monthly Progress Reports.
• Analyse Subcontractor’s progress report, identify and highlight schedule deviations and delay.

Education Qualifications and other Requirements

• Degree with extensive Project Control experience on major projects working in a contractor environment is preferable.
• Excellence in Microsoft Excel, Microsoft Project and Primavera version 6 (and above) application is a must.
• Minimum 6 to 7 years planning & scheduling in EPC sector is a must.
• Familiar with standard software programs, developing S-Curve Schedule, bar-charts and manpower histogram is a must.

Skill Requirements

• Demonstrated success in past project involvement and technical delivery of medium to large size projects.
• Possesses wide and diversified knowledge of project control system, scheduling and planning techniques in the Oil & Gas and Petrochemical Industry, in particular EPC.
• Quality & Safety Awareness / Accountability.
• Organisational Alignment.
• Technical Skill & Work Performance.
• Teamwork (Cooperation and Coordination).
• Effective Communication.
• Integrity and Trust.

Responsibilities:-

• Person in charge of the workplace on environmental regulations pertaining to the Environmental Public Health (Registration of Environmental Control Officers) Regulations 1999 Person in charge of the workplace implementation and revision of Environmental Management in the worksite
• Act as an Earth Control Measures Officer (ECMO)
• Establish, update, maintain, and implement the Environmental Management System and Environmental Impact Aspect assessment
• Conduct / Plan site environmental inspection and ensure effective implementation and continual improvement on all environmental matters. Advise occupier of the workplace or other person in charge of the workplace on environmental health problems and recommend remedies to establish a healthy working environment
• Oversee the installation of noise meters at site vicinity and monitoring of construction works noise to ensure it does not exceed the permissible noise levels throughout various stages of construction phases
• Coordinate with external pest control operator visits to carry out fumigation, mosquito oiling and rodent control measures. This is to ensure effective control on site
• Liaising with National Environment Agency & Public Utilities Board (PUB) on environmental issues and other statutory requirements of compliance by sites
• Updates on codes of practice & environmental literature and circulates information to each level of employees

Requirements:-

• Must possess Environmental Control Officer Certificate and registered with National Environmental Agency (NEA)
• Min 2 years’ relevant experience

Responsibilities:-

• Person in charge of the workplace on environmental regulations pertaining to the Environmental Public Health (Registration of Environmental Control Officers) Regulations 1999 Person in charge of the workplace implementation and revision of Environmental Management in the worksite
  Act as an Earth Control Measures Officer (ECMO)
• Establish, update, maintain, and implement the Environmental Management System and Environmental Impact Aspect assessment
• Conduct / Plan site environmental inspection and ensure effective implementation and continual improvement on all environmental matters. Advise occupier of the workplace or other person in charge of the workplace on environmental health problems and recommend remedies to establish a healthy working environment
• Oversee the installation of noise meters at site vicinity and monitoring of construction works noise to ensure it does not exceed the permissible noise levels throughout various stages of construction phases
• Coordinate with external pest control operator visits to carry out fumigation, mosquito oiling and rodent control measures. This is to ensure effective control on site
• Liaising with National Environment Agency & Public Utilities Board (PUB) on environmental issues and other statutory requirements of compliance by sites

Requirements:-

• Must possess Environmental Control Officer Certificate and registered with National Environmental Agency (NEA)
• Min 2 years’ relevant experience

You’ll get to:

• As a Quality Engineer, you have the opportunity to accelerate the delivery and to improve the quality of the software we build through recommending and implementing automated test suites.
• Work with vendors, government agencies and teams to identify end-to-end test scenarios as well as to automate these test scenarios, applying risk-based strategy to minimize manual interventions.
• Analyse and decompose complicated software systems and design a strategy to test these systems.
• Review Quality Assurance Plan and Test Strategy to provide timely and meaningful feedback.
• Ensure all required testing documentations are in place as part of production preparation checks.
• Drive and advocate continuous improvement in testing practices and tools.
• Conduct research on emerging test automation technologies that can optimize and accelerate the project delivery.

What you’ll bring to the team:

• Degree or Diploma in Computer Science, Computer or Electronics Engineering, Information Technology, or related disciplines
• Minimum 5 years' experience in application exploratory testing and regression test automation, application performance testing, and/or application security testing. Hands-on experience in automating various types of tests such as unit tests, API tests, Integration Tests, UI Tests, and End-to-end Tests.
• Create and support test automation strategies and implementations
• Knowledge of test best practices, test methodologies and their corresponding tools.
• Must have strong troubleshooting and debugging skills
• Meticulous attention to details
• Strong analytical, interpersonal and presentation skills
• Keen to share knowledge with team mates
• Curious, open to new ideas
• Quick to learn new skills
• Proactive, self-driven and motivated

Bonus points for:

• ISTQB, CSQA, CSTP or other relevant certification
• Excellent verbal communication and listening skills
• Experience in agile development environment will be an added advantage
• Experience in DevOps will be an added advantage
• Experience in Performance testing will be an added advantage

About Us

Green Link Digital Bank is Singapore's inaugural wholesale digital bank focusing on supply chain finance, mainly serving MSMEs and aiming to help MSMEs grow and improve digitization.

Responsibilities

• Review and approve onboarding of high-risk customers.
• Provide AML/KYC advisory on name screening, KYC documentation, and onboarding related issues/red flags escalated by front line.
• Obtain approval from the Bank’s senior management to establish or continue business relations with the high risk rated customer.
• Overseeing the carrying out of ongoing monitoring of account relationships.
• Maintain and update local internal blacklist in the AML System, overseeing that the Bank has adequate arrangements to perform AML screening of its customer database.
• Participate in system implementation and UAT, system enhancements, identification of system gaps and evaluation on the system capabilities/functionalities to enhance control effectiveness and efficiency including exploring the use of system automation such as AI, RPA and advance DA models.
• Extend support/help to transaction monitoring & STR team where needs arise.

Requirements

• A recognised University Degree or relevant professional qualifications in financial services or audit.
• 3 - 5 years’ experience in AML compliance within the banking, digital assets and/or relevant fields.
• Familiarity with payments and cryptocurrency AML and sanctions program.
• Familiar with MAS regulations in relation to ML/TF.
• Interest in the digital payment tokens and/or DPT service provider’s space.
• Good interpersonal and communication skills.
• Resilient and takes well to criticism.
• Adaptive, proactive, independent, and resourceful.
• Embodies teamwork.

Maintain standards and quality processes in food manufacturing operations;

• Conduct daily in-process quality control inspections at production lines to ensure alignment with internal requirements and Good Manufacturing Practices
• Maintain integrity, accuracy and completeness of QC data and records
• Perform routine calibration and maintenance of equipment
• Assist in export documentation consolidation and Health Certificate application
• Assist in monitoring and inspecting company infrastructure, equipment and utilities
• Develop and implement quality control procedures and protocols to improve overall product quality and consistency.
• Inspect in-coming and out-going products according to receiving and shipping policy
• Review and validate supplier raw material records and results (COA)
• Process improvements initiatives across the company

Conduct tests for food quality and packaging;

• Sensory evaluation of products aligned with specification
• Perform product sampling for laboratory tests

Rectify non-compliance issues (Customer Complaints / Audit findings);

• Support traceability investigations into lapses in quality, hygiene standards and non-compliance to quality standards. Conduct investigation and follow up with corrective action

Conduct training for production staff on quality control procedures, GMP practices, and food safety protocols;

Job Requirements

• Minimum 1 year of relevant working experience / Diploma in Food Science or related field.
• Knowledge of food safety standards and GMP principle
• Proactive, willing to learn and good follow-up skills
• Able to work independently with minimal supervision

Interested applicants are invited to apply directly at the NUS Career Portal

Your application will be processed only if you apply via NUS Career Portal

We regret that only shortlisted candidates will be notified.

Job Description

The job holders are to work with PI and the research team to process air quality data and study small-scale dispersion of airborne pollutants in urban environment.

Qualifications

One or more of (but not limited to) the following:

• Bachelor Degree in Engineering or relevant field
• Experiences of (small-scale) simulations of air pollutant dispersion, meteorology modelling, data processing
• Demonstrating as a fast learner of conducting literature study and literature summary
• Experiences of handling big data via R, Python, Matlab, etc.
• Experience with UNIX-based operating systems and bash script or similar
• Strong interests in applying machine learning models and applications to atmospheric research
• Proactive in assisting and contributing to quality scientific research publications
• Proficient in technical presentation, slide making, report writing, etc.
• Proven rounded and effective team player with strong initiative and ownership of the research project

AEDAS is a leading global design practice dedicated to creative excellence and diversity in the built environment. We are a global platform for the most talented architects and designers, focused upon delivering locally-celebrated solutions for cities, communities and clients. Our global network of 12 offices forms a diverse staff base with skills across all sectors in architecture, interior design, building consultancy, master planning, landscape and urban design.

To support our continuous growth and expansion in Asia, AEDAS Singapore is seeking a committed candidate for the following position:

DOCUMENT CONTROL ASSISTANT / DOCUMENT CONTROLLER

Responsibilities:

· To take direction from Document Control Manager

· To be able to work as a proactive team member

· Management & filing of all Project documentation (Outgoing & Incoming)

· Preparation of Document Issue Packages to meet Project stage deliverables as defined by the Project Team Leader

· Checking that all documents meet defined AEDAS standards before being transmitted, and to highlight non-compliances to team members responsible. i.e. File name & drawing nomenclature compliance (Checked against any earlier revisions).

· Maintenance of Electronic PDF in project folders reflecting:

o AEDAS “Current“ Documents (Drawings, Specifications, Reports)

o “Current” Documents from all other Consultants

o “Current” Documents from Contractors as Submission Packages documents

· Downloading, Internal distribution and eventually filing of contractor submissions

· Uploading of commented documents via Workflow

· Assistance in preparation of and updating the distribution matrix as and when required, and advising all changes as appropriate

· Production of Reports to include but not limited to;

o Incoming & Outgoing reports on a weekly basis

o Tracking registers to record receipt & return of submittals

o To maintain & manage RFI tracking lists

o To highlight to team leaders any late items not yet responded

o Other reasonable tasks as required by Doc Control Manager & Team leaders

Requirements:

· Document Control Assistant - 1 year of working experiences in Electronic Document Management System (EDMS) environments, such as Aconex, Procore & BIM360 Documents

· Document Controller - 4 years of working experiences in Electronic Document Management System (EDMS) environments, such as Aconex, Procore & BIM360 Documents

· To fully engage with the usage of Electronic Document Management System (EDMS) and any other electronic document control systems pertinent to a project.

· Illustrate a positive, proactive attitude

· Logical approach to work with a consistent attention to detail

· A full understanding of AEDAS IMS and its supporting documents

· Ability to cope with conflicting demands, to be able to proactively highlight any conflicts of priorities and suggest action plans to resolve issues

Please submit a copy of your updated CV including your current salary, expected salary and notice period to daisy.sim@aedas.com.

Job Responsibilities :

The Global Head of Ethics and Compliance will lead the Ethics and Compliance function in developing and enhancing compliance and regulatory policies and practices Razer businesses worldwide. This Senior Director-level role will report to the Chief Corporate Officer and work closely with the Legal team and operational compliance leaders in the various business units to ensure adherence to all applicable laws, regulations, and ethical standards.

• Serve as Ethics and Compliance partner to business units and other functions providing relevant advice to the rest of Razer.
• Build the Global Ethics and Compliance team and create visibility and awareness of the Ethics and Compliance practice across the organization, in adherence to legal and regulatory requirements, as well as Razer’s ethical standards.
• Design and build Ethics and Compliance policies and procedures relating to various aspects of our operations including trade compliance, product compliance and anti-bribery/ corruption.
• Collaborate with internal stakeholders such as Legal, HR, Internal Audit, Supply Chain Management, Razer Gold Compliance, FIUU Compliance, Information Security, Sustainability and Engineering to integrate compliance and ethics into daily operations and decision-making processes.
• Lead, conduct, and manage investigations, inspections, and audits as required.
• Lead discussions with regulators and other third parties and serve as Razer’s representative with external bodies.
• Develop and deliver training programs to promote a culture of ethics and compliance across the organization.
• Stay abreast of industry trends and best practices in ethics and compliance to continually improve Razer’s ethics and compliance program.

Pre-Requisites :

• A recognized degree in Law, Accountancy, Business Management, Finance, or equivalent.
• Minimum 15 years’ experience in a similar compliance or regulatory role covering various compliance areas such as personal data protection, anti-bribery, trade sanctions, and ethics and conduct.
• Relevant experience working for an MNC in consumer electronics or manufacturing.
• Knowledge and familiarity with the laws and regulations in key jurisdictions such as USA, PRC and EU.
• Experience in managing compliance processes and procedures such as management of bribery or sanctions red flags, vendor risk management.
• Able to lead the development and roll-out of compliance training programs across different jurisdictions and offices.
• Candidate must have the inclination to quickly develop an acute understanding of the Razer business and be determined to grow and develop the function and team.

Job Summary

• Minimum 5 or more years of Manual testing work experience
• Hands-on experience with Functional testing/SIT testing
• Strong knowledge of software QA methodologies, tools, and processes
• Experience working in an Agile/Scrum development process and expert in using Jira
• Banking Domain knowledge (Good to have but not limited to: Client Onboarding/customer onboarding system)

Primary Purpose

Reporting to the Senior Manager, Supply Chain SMO/COE, the Master Data Quality & Governance Manager plays a vital role in ensuring the accuracy and integrity of master data and will be responsible for overseeing and implementing data governance strategies, policies, practices, and processes across the Asia Pacific region. This role is also responsible for collaborating with APAC business stakeholders to understand their data needs and requirements and ensuring data quality standards, processes and procedures align with business objectives, and providing training and support to business stakeholders on data quality best practices.

Develop and Implement Data Governance Framework:

o Design and establish a comprehensive data governance framework across the Asia Pacific region.

o In partnership with Global Data Governance teams define data governance policies, procedures, and standards to ensure consistent and accurate data management practices.

o Collaborate with stakeholders to gain buy-in and support for the data governance initiatives.

Data Stewardship and Ownership:

o Establish data quality rules, monitor data compliance, and resolve data-related issues.

o Ensure data ownership and accountability by establishing data governance and execution roles and responsibilities.

o Drive continuous improvement by monitoring data governance performance and identifying opportunities for enhancement.

o Conduct regular data audits and assessments to identify gaps and recommend corrective actions.

o Collaborate with cross-functional teams, including IT, finance, operations, privacy and legal to ensure alignment and compliance with data governance initiatives.

o Engage with global stakeholders to share best practices, leverage synergies, and contribute to the overall data governance strategy.

Training and Awareness:

o Develop training programs and materials to educate employees on data governance policies, procedures, and best practices.

o Raise awareness of the importance of data governance and its impact on business operations and decision-making.

o Provide guidance and support to business units in implementing data governance practices effectively.

o Act as a subject matter expert, providing guidance and support to stakeholders on data governance-related matters.

Inherent Requirements

Formal Qualifications

Bachelor's in information management, computer science, business administration, or a related field.

Key Skills / Core Competencies

• Strategic thinking ability, as well as detailed analytical and problem-solving skills
• Strong communication and relationship building skills to collaborate cross functionally with internal partners and external customers.
• Comfort in managing relationships with senior leadership.
• Strong entrepreneurial, customer service orientation.
• Ability to effectively prioritize, execute tasks and manage deadlines in a high-pressure environment.
• Good written, oral, and interpersonal communication skills.
• An ability to work well in an ambiguous environment with minimum supervision.
• Strong professional presence and business acumen.
• Innovative, proactive, and flexible to change.
• Self-motivation and a strong sense of ownership and accountability
• Exposure to process improvement methodologies with Lean Six sigma Green or Black belt an advantage

Experience

• Proven experience in data governance, data management, or related roles, preferably within a multinational organization operating in the Asia Pacific region.
• In-depth knowledge of data governance frameworks, principles, and best practices.
• Strong understanding of data quality management, data privacy regulations, and data-related compliance requirements.
• Demonstrable experience leading process change
• Superior vendor management experience
• Demonstrable knowledge and experience in SAP, SFDC, M365, BI and data analysis tools.

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development,
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.

We are looking for people who

• See beyond themselves and are impact-focused,
• Consider the needs, challenges, and objectives of every person with whom they interact, and
• Exhibit positive reinforcement to help others succeed.

About the role

Works closely with and have impact on: Global Quality Assurance Team

Reports to: Senior QA Engineer

Function: Global QA

Work Location/Site: Singapore / GHQ

Internship Duration: Any 3 months between January to May 2025

Role Overview

The QA intern will support the quality and various project teams with validation needs in MasterControl, our cloud-based Quality Management System (QMS) for HSO.

Duties and Responsibilities

• Assist to perform validation duties to ensure software validation project and corresponding deliverables adhere to current regulations and quality standards
• Actively contribute towards continuous improvement of the quality team by suggesting new ideas and promoting innovative culture through improving and optimizing analysis of quality data and process workflows
• Provide support to record management and archiving activities
• Support post-migration and improvement activity works for the QMS
• Assist with QMS Modules improvement and maintenance activities
• Participate in team activities and initiatives related to QMS and regulatory requirements
• Other duties as assigned

Requirements

Experience

• N/A

Skills/Accreditations

• Microsoft office skills essential. Candidates with Excel Macro skills preferred
• Some Quality system knowledge will be advantageous
• Self-awareness and Good work ethics
• Strong communication and interpersonal skill

Academic Qualifications

• Pursuing Diploma or Degree Preferably in Science or Engineering

Travel requirements

• N/A

By submitting your application, you agree that your personal data will be collected, disclosed, and retained by HOYA Group for assessing suitability for employment and verification purposes.

We regret to inform you that due to the number of applications received, only shortlisted applicants will be notified. Thank you for your kind understanding.

About HOYA Surgical Optics (HSO)

HOYA Surgical Optics (HSO) is the globally leading Preloaded Intraocular Lens (IOL) focused company that provides technologies and solutions that exceed expectations, enabling ophthalmic surgeons to focus on restoring sight. We are dedicated to improving the vision and quality of life for millions of people suffering from cataract, and helping them celebrate life visually.

HSO empowers cataract surgeons all over the world with innovative ophthalmic devices and services, with an attention to detail that helps them achieve better surgical outcomes and better practice results. Our commitment to delivering these results is grounded upon a quality management system that is continuously improving to meet changing global regulatory requirements and our entrepreneurial drive to be the brand of first choice.

At HSO, People is the key factor to our success. We aim to create a conducive work environment for our employees around the globe, and to promote an inclusive culture based on our core values – Excellence, Passion, Innovative, Collaboration, and Accountability.

HSO way of working

In fulfilling our roles, we are

• Accountable for our own capabilities and development,
• Focused on delivering results without excuses, and
• Alive to the sensitivities, risk, and impact we have on others and work in a way that helps others do their work effectively.
• We are looking for people who
• See beyond themselves and are impact-focused,
• Consider the needs, challenges, and objectives of every person with whom they interact, and
• Exhibit positive reinforcement to help others succeed.

About the role

Works closely with and have impact on: Global Research & Development (R&D), Post Market Surveillance, and Global Regulatory Affairs (RA) Teams

Reports to: Senior Manager QA R&D

Function: Global QA & Compliance Organization

Work Location/Site: Singapore / Global Headquarters

Role Overview

This position is responsible to ensure that products meet quality goals and regulatory requirements, including but not limited to FDA Regulations, ISO 13485, EU MDR requirements, and Risk Management per ISO 14971 and maintain compliance of the Quality Management System (QMS).

Duties and Responsibilities

• Partner with R&D teams in the USA, Japan, and Singapore to ensure that design control is completed in accordance with procedures, WI, regulatory requirements, and assure that required outputs have been completed
• Execute risk management for devices, processes, and provide the assessment results from product development through to the launch
• Maintain and update risk management files with Global R&D/Manufacturing Engineering (ME) teams to support product development (Risk Management Plans, Risk Control Log, Benefit Risk Assessment Risk Management Report, xFMEA, etc.), and act as the Risk Management expert
• Assist in the review and approval of design development plans, verification and validation protocols, reports, master V&V plans and reports, and design transfer
• Review and approve design verification test protocols, reports and data from a logical point of view (Compliance, rationale, objectiveness and statistics)
• Partner within Quality and R&D to ensure design control documentation (Risk Management, Traceability/Linkages) & design change control requirements are met
• Review and approve biocompatibility protocols and reports
• Ensure compliance of IQ, OQ, tests method validation, Standard Operating procedures and work instructions regarding product development
• Maintain compliance to QMS procedures of the R&D Singapore site, and support the Singapore R&D Site - QA
• Support External audits by competent authorities and notified bodies
• Support internal audits at the local site, and other sites as required
• Review and approve other quality documents (e.g., IQ, OQ, PQ, WI, etc) within areas of responsibility
• Propose and execute quality/process improvements. Write/review policies/ processes/ procedures and related documents
• Manage and monitor the progress of the calibration and maintenance of testing equipment. Ensure calibration or maintenance records satisfy regulatory and QMS requirements (act as Equipment Control Administrator in Singapore)
• Participate in development projects and change control request meetings to support the resolution of engineering issues
• Collaborate with the post-market surveillance team and complaints investigation teams to maintain risk management process throughout a product’s lifecycle
• Provide support for other quality activities and improvement initiatives, quality data collection and trending, CAPAs, change controls, training, etc.
• Support initiatives as identified by management to support QMS and other regulatory requirements in Singapore

Requirements

Experience

• At least 4+ years of Industry experience working as QE Engineer in Medical Device/ Pharmaceutical product or optical engineering business field
• Experience in test method validation
• Experience in Design control, Design Transfer, Design and Development Process
• Demonstrated knowledge of Risk Management (ISO14971), Design control, Design and Development Process and Quality System (any one of ISO13485).
• Understanding and Knowledge of biocompatibility studies
• Experience in coordination and planning of complex activities and ability to identify and resolve complex problems through effective use of technical and interpersonal skills
• Product development experience (e.g. approaches for definition of requirements and specification setting for verification and validation). Practical experience in design control and risk management
• Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues
• Interpersonal, team, leadership, and negotiation skills to handle conflicting priorities
• Strong oral and written communication skills, excellent interpersonal and cross-cultural skills required
• Capable of clearly presenting and justifying quality requirements to management
• Accreditation by a professional body is highly desirable. Examples include American Society for Quality (ASQ) Certified Quality Auditor (CQA) or Certified Quality Engineer (CQE)

Skills/Accreditations

• Smooth communication ability
• Business software skills (e.g. Word, Excel and Power point)
• Experience with statistical software such as Minitab
• Voluntary working attitude with a creative idea
• Passionate working attitude to pursue a goal with patience.
• Flexibility for changes

Academic Qualifications

• A bachelor’s degree or higher in Chemical, Bioengineering, Mechanical, Optical Engineering or related fields.

Travel requirements

• 2-3 international travel annually mainly Thailand.

By submitting your application, you consent to HOYA Group collecting, disclosing, and retaining your personal data for employment assessment and verification purposes.

If you are shortlisted, we will contact you within three weeks of your application. Thank you for your application and understanding.