Total 340 Quality Assurance / Control job vacancies in Tai Po, New Territories

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.

Job Duties:

• Manage the process for QMS audits, to ensure compliance of the organization’s Integrated Management Systems wrt ISO9001/TS16949/ VDA 6.3, Customer specific requirements.
• Identify areas/ system gaps for improvement and implementation. Establish and drive QMS enhancement and integration roadmap/milestones.
• Work closely with Operations and key stakeholders to maintain consistent manufacturing, quality policies and compliance
• Responsible for maintaining/improving fab performance though SPC program.
• Investigate root causes and resolve key fab-related quality issues and effectiveness of corrective and preventive actions. Manage Non-Conformance cases with respect to on-time closure with the relevant customers/Business Lines.
• Responsible for Outgoing and Periodic review OQA performance to drive defect reductions
• Responsible for Document Centre Management & Library Services
• Management of change among diverse cultures in a fast paced environment
• Co-work with related functions to support the wafer fabrication process to drive process/system optimization and effectiveness

Job Qualifications:

• Degree in Chemical / Electrical Engineering / Physics / Chemistry or equivalent
• 8+ years in semiconductor industry preferred
• Knowledge of wafer fabrication process essential
• Strong in project management skills, facilitation, analytical skills and system thinking

• Serve under the general supervision of the Supervisory Fire Inspector (Captain), who makes assignments based on the overall policy and general content of the fire prevention program.
• Operate within an assigned inspection area to include high-risk, conducting comprehensive fire/safety inspections to identify and correct hazardous conditions.
• Identify complex unique hazards and devises corrective measures.
• Conduct public education classes post-wide as well as on-the-job training classes for fire department personnel.
• Provide training in general fire/safety subjects as well as issues unique to a particular activity.
• Conduct review of architectural drawings and specifications to determine compliance with fire/safety regulations and evaluates special features impacting the fire protection mission.
• Respond to emergency incidents as part of a firefighting team, performs a full range of firefighting duties at all types of emergency incidents, maintaining a degree of firefighting proficiency sufficient to perform firefighting tasks.

• If selected at the GS-11 level, duties will be performed in a developmental capacity.
• Plans/executes engineering and technical functions related to engineering, manufacturing, and quality assurance.
• Develops and/or implements agency engineering and quality assurance policies, tools, and training program.
• Provides authoritative guidance and advice to management, customers, and Quality Assurance Specialists in functional area of expertise.
• Resolves complex technical problems associated with surveillance of major, critical contracts for program life cycle stages, next generation equipment, or DoD Weapon Systems.

• If selected at the GS-11 level, duties will be performed in a developmental capacity.
• Plans/executes engineering and technical functions related to engineering, manufacturing, and quality assurance.
• Develops and/or implements agency engineering and quality assurance policies, tools, and training program.
• Provides authoritative guidance and advice to management, customers, and Quality Assurance Specialists in functional area of expertise.
• Resolves complex technical problems associated with surveillance of major, critical contracts for program life cycle stages, next generation equipment, or DoD Weapon Systems.

• Designs/implements/maintains a risk-based surveillance program and assessment plan associated with the quality assurance provisions of contracts.
• Identifies opportunities for process improvements by analyzing data.
• As a member of a multi-functional or technical team, implements the overall Quality Program for diverse products and services to support the U.S. Government’s acquisition at one or more supplier facilities.
• Ensures contractor compliance with design, manufacturing, repair, overhaul, and modernization requirements.
• Independently audits/surveys contractor processes to ensure compliance with customer/contractual requirements.
• Investigates customer complaints/concerns about contractor quality performance and processes which impact user satisfaction, then provides data about the complaints.
• Provides technical support to DCMA team members, assisting with analyzing contractual issues, and determining the best course of action to support the contractor and customers.

Job Decription:

• Attend to customer quality issues.
• Improve manufacturing processes and products
• Provide quality services to ensure compliance with the quality system
• Achieve quality targets of products

Requirements :

• Diploma / Degree in Engineering
• No Experience are required
• Good interpersonal and communication skills
• Proficiency in spoken and written Chinese is required to deal with Chinese stakeholder

HOW TO APPLY:

Interested applicants, kindly send your resume in MS WORD format to leo.tang(at)trustrecruit.com.sg

We regret only shortlisted candidates will be notified.

Important Note: Trust Recruit Pte Ltd is committed to safeguarding your personal data in accordance with the Personal Data Protection Act (PDPA).

Please read our privacy statement on our corporate website www.trustrecruit.com.sg.

Trust Recruit Pte Ltd

EA License No: 19C9950

EA Personnel: Tang For Farn (Leo)

EA Personnel Reg No: R24121981

Summary

This position is accountable for supervising quality control inspection work of steel structural, Equipment, piping including painting/ insulation and other permanent materials installed for the facility so that the construction work can be completed meeting with the Schedule, quality, and Safety requirements.

He will be assigned to work under JGCAP’s Site In-charge/ Project Manager. He shall monitor the subcontractor’s quality control work plan, day to day inspection, performance, other quality activities and report to the JGCAP’s Site In-charge/ Project Manager.

Daily progress of quality control inspection works and problems shall be immediately reported to the JGCAP’s Site In-charge/ Project Manager and ask for his instruction, which should be conveyed to the relating sections without delay and shall be supervised to complete/ repair/ re-work on such issue.

Roles and Responsibilities

• Receive the instruction of the job to be in his duty from JGCAP’s Site In-charge/ Project Manager.
• Receive the orientation of the field office function from JGCAP’s Site In-charge.
• Receive all required safety induction course from JGCAP’s Safety Lead or his assigned Supervisor.
• Review the latest status of “For Construction Drawings” and Specifications For Construction” and ensure that the same Drawings and Specifications are used by the subcontractor, and if not, make sure the Execution Implementation Contractor (EIC) collects the latest issues.
• Monitoring, checking and leading Execution Implementation Contractor (EIC)’s QC activities.
• Coordinate quality related meeting and or for inspections with client, follow by expediting subcontractor’s Quality Control inspection/ third party’s inspection for the preparation and submission of required inspection reports.
• Site Coordinate/ liase with authority for MOM Pipelines.
• Prepare required Quality Control report either on a daily, weekly and monthly basis to JGCAP’s Site In-charge/ Project Manager including daily Quality Control activities, non-conformance and document status.
• Reporting the status of Quality work progress and monitor/ tracking the punch in or out to the JGCAP’s Site In-Charge.
• Attend Quality Control meetings with subcontractors being conducted by the JGCAP’s Site In-charge/ Project Manager as well as the Execution Implementation Contractor (EIC) Weekly Construction Meeting, which is usually chaired by respective Discipline Lead.
• Any other work required for QC activity under direction of the JGCAP’s Site In-charge/ Project Manager.

Requirements:

• Diploma or equivalent or above.
• Experience on welding inspection, preferably of the level of CSWIP Level 3.2 (Certification Scheme for Welding Inspection Personnel), AWS, NDE, NACE certificates.
• At least 5 years’ relevant working experience in oil/gas/petrochemical plant construction.
• Able to understand piping drawings (Plot Plan, Piping Layout, Piping Isometrics, Pipe Spool drawings), P&I diagram, Line index, Specifications and Procedures.
• Able to interpretation of ASME X, VIII, XI codes, B31.3 Process Piping Codes.
• Familiar with international codes such as ASME, ANSI, ASTM, NFPA, BS etc.

Interested parties, please send in your detailed resume.

The POI receives administrative direction from management in terms of broadly defined missions or functions. The POI, mostly independently plans, designs, and carries out programs, projects, studies, or other work. The APO provides policy assistance to field level Aviation Safety Inspectors (ASIs) on difficult or complex policy interpretations. The work is normally accepted without change. Completed work may be reviewed for adherence to FAA policy and for assurance that project requirements have been fulfilled.

ASIs at the FG-13 level issue certificates to and monitor (1) a large and complex aviation organization or (2)a number of smaller organizations that, together, are comparable in complexity to one large one. They are the primary contact point with the aviation organization(s). They may decide on issuance of the original certificates. They evaluate and decide upon proposals to change the authorized programs of the organizations. They continuously monitor the activities of organizations to determine whether they are following their authorized program, Federal regulations, and good safety practices.

FG-13 assignments are characterized by one or more of the following:

1.Multiengine turboprop, turbojet, or rotorcraft helicopter aircraft;

2. A variety of flight operations with diverse types of aircraft which may include turbine powered aircraft and unmanned aircraft; or

3. Novel and complex aviation operations.

FG-13 employees plan and conduct their assignments with substantial technical independence. They receive administrative and policy guidance from their supervisors and policy makers. They also obtain technical advice from higher-level inspectors who are experts who have overall program responsibility. They independently plan and carry out a work program to meet the needs and monitor the activities of the organizations for which they have certification responsibility. The scope and complexity of the work program may be such as to require the occasional assistance of other employees to conduct inspections and evaluate operations.

The POI applies a mastery knowledge level of the appropriate specialization and a broad knowledge of the
line of business mission and goals to assigned programs and areas of responsibility.

The POI plans and directs the use of time and resources to accomplish organizational objectives. He or she defines, organizes, and uses resources to accomplish work activities within established schedules, analyzes program requirements and accomplishments, and makes or directs adjustments as necessary to address organizational needs.

Guidelines and precedents are frequently inadequate for dealing with novel or complex operations. FG-13 employees understand and apply the basic principles of aviation safety and interpret the intent of the regulations.

At FG-13, contacts are frequently with owners and top managers of aviation corporations and involve negotiating and resolving the full range of issues and problems that confront large aviation organizations. Occasionally issues are controversial, arousing considerable public interest.

ASIs at the FG-13 level participate extensively in the certification inspection and surveillance of highly complex air carrier operations where principal program responsibility is vested in an aviation safety inspector of higher grade. These FG-13 employees have broad authority to negotiate with carrier management and make technical determinations within the coverage of approved specifications and policy manuals.

The POI provides guidance to field level staff to solve difficult technical issues. Resolves all but unique problems with the intervention of management or a technical specialist. Develop plans, techniques, and policies to address current and anticipated problems and issues. Works with management to solve problems.

Contacts are internal and external to the agency. The inspector is required to maintain an FAA second class medical.

Performs other duties as assigned.

The PMI receives administrative direction from management in terms of broadly defined missions or functions. The PMI, mostly independently plans, designs, and carries out programs, projects, studies, or other work. The PMI provides policy assistance to field level Aviation Safety Inspectors (ASIs) on difficult or complex policy interpretations. The work is normally accepted without change. Completed work may be reviewed for adherence to FAA policy and for assurance that project requirements have been fulfilled. Some FG-14 assignments involve Service wide responsibility for application of expert knowledge of general aviation maintenance. Other FG-14 inspectors establish technical procedures and performance yardsticks and review maintenance programs, or who have problems of comparable scope and complexity, or a uniquely complex group of general aviation organizations. Assignments at this level are of great scope and unusual complexity and the organizations monitored are major factors in the industry. ASIs at the FG-14 level establish technical procedures and performance indexes and review complete maintenance programs for general aviation organizations who are leaders in the aviation industry, or who have problems of comparable scope and complexity, or a uniquely complex group of general aviation organizations. Assignments at this level are of great scope and unusual complexity. The following assignments are illustrative:

1.As a Service wide expert on a particular type of aircraft:

-- Advises other inspectors of major changes;

-- Evaluates new training methods and equipment;

-- Serves on boards that evaluate incidents, accidents, complaints, and other serious problems relating to the aircraft.

2.As the principal representative in regulatory surveillance of general aviation activities, exercises certificate authority; or evaluates maintenance activities and complete aircraft overhaul facilities (By comparison, FG-13 employees exercise certificate authority over less complex air carriers or perform major portions of the certification, inspection, and surveillance for major carriers under the direction of FG-14 inspectors.)

3.Exercises certificate authority and safety responsibility over a complex of broad and varied general aviation organizations such as air taxis, executive and/or industrial operators, repair stations, and flightand mechanic schools when the activities monitored equate collectively to a major air carrier in terms ofsize and complexity of aircraft fleet employed, scope and technical complexity of operations, management sophistication, industry leadership, and public impact. The magnitude, intensity, and scope of program responsibility are typically such as to require significant and regular assistance of lower graded inspectors.

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 Research Fellow will work closely with the Principal Investigator, Dr. WU Zhe, on several research projects of optimization of chemical and manufacturing processes through machine learning tools
• The Research Fellow will help to develop both theoretical and simulation study of machine-learning-based control and optimization algorithms to chemical processes.

Job Requirements

For Research Fellow Position:

• A PhD degree in a relevant area, e.g., Control Engineering, Chemical Engineering, Automation, Systems Engineering, Computer Science or Applied Mathematics;
• Good publication record;
• Experienced in advanced process control, machine learning, and programming languages (e.g., python, Matlab, C++, etc)

• YOU WILL/MAY:
• Ensure that regulated establishments produce a safe product by executing appropriate inspection methods, determining non-compliance with regulatory requirements, documenting noncompliance and initiating enforcement actions, where warranted.
• Verify that meat and poultry slaughter and/or processing establishment's Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans meet regulatory requirements.
• Execute Sanitation Standard Operating Procedures (SSOP) and Hazard Analysis and Critical Control Point (HACCP) Plans effectively to prevent unsanitary conditions and adulteration of product.
• Review records, observe plant operations and conduct hands-on verification to ensure compliance with regulatory requirements and prepare detailed documentation (Non-Compliance Records) of non-compliance with regulatory requirements.
• Determine when regulatory control action is necessary. You will assess whether the plant's corrective or preventative actions are acceptable and effective, if there are trends in noncompliance, or if an enforcement action is warranted.
• Conduct regulatory oversight activities inside plants in matters relating to other consumer protections (e.g., economic adulteration and misbranding).
• Have contact with plant managers, owners and others to explain legal and regulatory requirements, discuss operation of the plant's SSOP, HACCP plan and other food safety programs.
• Communicate and defend determinations on non-compliance issues and discuss plans for addressing non-compliance.
• Work with a variety of individuals to resolve problems, clarify differences of interpretation concerning HACCP and other food safety or consumer protection requirements.
• Advise other Agency inspectors, supervisors and officers on inspection and enforcement matters for which you are involved.
• Conduct various samplings, surveys and tests to obtain pertinent data on potential problem areas, industry trends, or other issues of current interest to the Agency.
• Be involved in performing health and safety verification sampling and tests for detection of specific microbes (e.g., salmonella, listeria, etc.), residues or contaminants.
• Assure that products approved for import are in full compliance with all applicable Federal regulations governing the importation of meat and poultry products.
• Authorize entry of all meat or poultry products considered to comply with Federal regulations or refuse entry of any products which violate any of the requirements for admission into this country.
• Coordinate with other Federal agencies (e.g., the Animal and Plant Health Inspection Service (APHIS) and U.S. Customs and Border Protection (CBP) on such matters as animal health restrictions and refused entry lots.

Supervises a staff of Air Traffic Control Specialists that is responsible for carrying out air traffic control assignments within a geographic area. Plans and assigns work to be accomplished by subordinate employees. Sets work priorities and schedules. Approves leave; gives advice, counsel, and instruction to employees on both work and administrative matters. Evaluates performance of employees and recommends performance ratings. Hears and resolves complaints from employees and refers group grievances and more serious unresolved complaints to a higher-level manager. Identifies and arranges for developmental and other training needs of employees. Finds ways to improve production or increase the quality of the work directed. Adjusts staffing levels and work procedures to accommodate resource decisions made at higher levels. Recommends goals and objectives for the area and tracks accomplishments. Communicates and reinforces diversity and EEO policies and programs in all areas of responsibility, including selections, training, and transfers. Supports and participates in the labor management partnership process, and fosters a work environment where all employees are treated in a fair and equitable manner. The Operations Supervisor reports to the Operations Manager. Performance is evaluated upon the effectiveness with which assigned program objectives are achieved.

About the Role:

This position has responsibilities for the deployment and standardization of key Quality Assurance activities including assurance of product quality, quality planning process, and maintenance of Quality Management System performance. This role will carry out responsibilities in strict adherence to regulatory requirements and applicable standards relevant to medical device, and always act with focus on quality objectives within the organization.

Roles and responsibilities:

• Functional lead for implementation, managing operational effectiveness of Complaint Handling process, trending activities, and analysis of data associated with defined KPIs.
• Responsible for monitoring and implementation escalation process and resolution for late medical device reports caused by late entries by local intake team.
• Analyze and recommend complaints received are reportable within the market, ensure adverse events reported to Authority if needed, with special attention to managing complaint-adverse event with close follow up with manufacturer and/or reporter.
• Execute, coordinate and feedback Field Corrective Action/Recalls with the countries, maintain tracking to monitor field actions in the region to ensure effective resolution or closure. Report Field Corrective Action to Authority if needed.
• Support audit readiness, conduct and prepare for regulatory/external audits as well as internal quality audits to ensure timely execution according to defined schedule.
• Participate of Nonconformity, Corrective and Preventive Actions, Documentations, Supplier Quality across the organization.
• Develop/update procedures for quality system processes to ensure alignment with Olympus global procedures as well as coordinate with other departments that effect Quality Systems.
• Provide training and support to employees concerning quality systems, policies, procedures, and core processes etc.
• Support global and local quality improvement initiatives and transformative projects.
• Execute other tasks and projects, as assigned by Manager.

About Olympus:

Our purpose at Olympus is to make peoples’ lives healthier, safer and more fulfilling. We do this through innovation. As a technology pioneer, we design and deliver solutions across our Medical division that make a positive contribution to society.

Our products are used to capture the medical and diagnostic images of our world, from the microscopic to the endoscopic. They are instrumental in furthering research, and for travelling inside the human body to help diagnose, treat and prevent illness.

Our commitment to customers and our social responsibility is the cornerstone of everything we do.

Why work at Olympus?

At Olympus, we are dedicated to fostering a high-performing culture, a collaborative environment, and enabling everyone to shine. Our common values of Patient Focus, Integrity, Innovation, Impact and Empathy, form the foundation of our culture and guide our behaviour, where our people feel like they are making a difference every single day.

Not only will you benefit from a meaningful, rewarding and challenging career, you will have access to a range of benefits:

• A competitive salary package including AWS and Variable Bonus
• Hybrid home office work arrangements
• 18 days of annual leave in your first year
• Health and Wellbeing initiatives (Annual Medical Checkups, Flu Vaccinations, Dental benefits, and Employee Assistance Programs)

What we are looking for:

• Bachelor’s degree in related field of engineering, science, or equivalent discipline.
• At least 5 years of experience working in similar position of responsibility in the medical device quality field
• Prior experience in managing quality management system in a medical device environment and quality assurance/regulatory compliance
• Must have knowledge to perform quality audit, certified auditor in ISO13485 or GDPMDS will be a plus.
• Strong knowledge of quality system requirements and medical device regulatory framework
• Meticulous and strong attention to details
• Excellent verbal and written communication skills
• Good problem solving and ability to drive change within organization
• Ability to succeed in a fast-paced, matrixed environment with speed, accuracy and adaptable to meet business need
• Positive attitude and able to work well as team player

Apply Now:

To submit your interest in this opportunity, select “Apply for this job”.

In the meantime, follow us on:

• LinkedIn - Olympus APAC
• Company website - www.olympus.com.sg

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.