Total 910 Quality Assurance / Control job vacancies in Welwyn Garden City, Hertfordshire

The Quality Assurance & Member Services Support Agent is required to monitor all sales calls as well as member support calls to ensure that the final service observes the company's quality standards. Besides, support Member Service tasks to satisfy member’s enquiries.

• Serving as a geographical area technical coordinator.
• Providing technical leadership and coordinating data collection, data quality control, handling and analysis for development, maintenance and use of ecological sites.
• Coordinating training, and overseeing work of state, field office, and soil survey office staffs.
• Collaborating with MLRA Soil Survey Offices in the assigned area to collect information for development, improvement and utility of Ecological Site Descriptions (ESDs)

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.

Job Responsibilities

• Oversee and provide guidance to QC Inspection Team to ensure implementation of all inspection-related activities according to standards, including proper disposition and handling of non-conforming material/product.

- Pre-inspection of designated goods (at warehouse).

- Sampling and QC inspection of incoming materials (pre-shipment samples, raw materials, bulk, semi-finished and finished products, packaging materials) and out-going products.

- In-process inspection to ensure that quality, hygiene, and safety standards are met.

• Identify and investigate OOS (out-of-specification) or NC (non-conformance) cases, analyse the root causes, and monitor closely the resolution and correction status.
• Investigate product feedbacks, analyse quality-related problems, and recommend problem resolution.
• Handle product stability tests.
• Work with relevant parties (e.g. external provider and product owner) to establish specifications and quality attributes of raw material, packaging and product, confirm appropriate test method for each QC parameter, and document evidence.
• Contribute for establishing and improving relevant QC SOP and inspection/testing-related work instructions (in compliance with GMP and ISO requirements).
• Ensure proper QC documentation including Master Specifications, QC Records (including electronic logs), QC Test Reports, Lab Test Reports, Non-Conformance Reports, COA etc.
• Ensure cleaning and environmental monitoring programmes for the site are done accordingly.
• Manage retention room for retention, reference and post-inspection samples, and sample retention system.

Requirements

• Degree in Science or Engineering (preferably in Cosmetic Science, Chemistry, Pharmacy, Nutrition or relevant field).
• Preferably 1-3 years of experience in the quality control of cosmetics, pharmaceuticals, dietary supplement, food, or skincare/medical device.
• Experience in a GMP environment or knowledge of GMP an important plus.
• Knowledge of relevant product standards, quality control and test methods.
• Stringent compliance to procedures, guidelines, standards, and regulations.
• Self-starter, good at working well independently with initiatives.
• Meticulous & detail oriented.
• Analytical & problem-solving skills.
• Time management skills (scheduling, prioritising) to meet deadlines.

• Serving as a geographical area technical coordinator.
• Providing technical leadership and coordinating data collection, data quality control, handling and analysis for development, maintenance and use of ecological sites.
• Coordinating training, and overseeing work of state, field office, and soil survey office staffs.
• Collaborating with MLRA Soil Survey Offices in the assigned area to collect information for development, improvement and utility of Ecological Site Descriptions (ESDs)

RESPONSIBILITIES

• The role involves planning, coordinating, and implementing standards development projects under the national standardization programme administered by Enterprise Singapore.
• Provide secretariat support to the Technical Committees and Working Groups. This includes preparation of agendas, meeting minutes, report compilation, drafting of standards, etc.
• Engage and coordinate with the industry, academia, and government organizations to facilitate the development, promotion, and review of Singapore Standards and Technical References.
• Organizing key standard launches events and other outreach events.
• Collaborate with key stakeholders to identify, develop, and launch new standards. This includes conducting consultations and ensuring that standards are aligned with industry needs.
• Assist in the industry and technical research for the development of new/review of standards. Conduct verification studies to identify users of the standards.
• Handle inquiries regarding standards in your area of responsibility, ensuring prompt and accurate responses to stakeholders.

Requirements

• Minimum Diploma qualification/ Fresh gradustes are welcome to apply
• Preferably with at least three (3) years of relevant work experience in safety or manufacturing related field
• Preferably with secretariat experience
• Min. 3 years of experience in quality, safety or manufacturing industry is advantageous
• Results-oriented and able to manage and execute projects in a team and independently.
• Possess good interpersonal skills and work well with various stakeholders
• Good writing and communication skills.
• Proficiency in Microsoft Word, Excel, PowerPoint, and other productivity tools

Major Duties:

The RN Quality Management Consultant (QARN) demonstrates leadership, experience, and creative approaches to improvement in quality-of-care outcomes. The QM Consultant demonstrates performance and leadership that is broad enough to improve the care for a group of patients. The QM Consultant is responsible for the documented outcomes at the program or service level. Program or service level outcomes must be broad and complex and can be demonstrated at any organizational level within a facility. Program is defined as a substantial coordinated group of activities impacting patients and/or employees.

The QM Consultant is assigned responsibility for their assigned quality management program area activities for the Medical Center and all off-site locations. The QM Consultant collects data, monitors staff compliance with relevant policies, directives, and standards, provides reports detailing trends, and provides direct staff support to all services in planning, designing, integrating, implementing, modifying, and administering, a comprehensive quality management program area. They participate in several facility councils, committees, and workgroups.

Executes the position responsibilities that demonstrate effective leadership, detailed planning, professional communication, creative and innovative approaches to the improvement of safety/healthcare program development and possess an ability to organize priorities. The QM Consultant works in concert with leaders and others to sustain a culture of safety, modeling High Reliability Organization (HRO) practices.

The QM Consultant performs duties directly contributing to high quality and safe patient care within the Veterans Health Administration (VHA). Duties require the ability to apply specialized principles and practices to ensure a systems approach to healthcare delivery. The QM Consultant directly supports facility leadership in areas of planning, organization, development, direction, and evaluation of the quality program within the facility.

Assumes a leadership role in the assessment and evaluation of data collected through the screening activities and available data sources and compiles and presents data using Microsoft and other available quality tools in a usable form for all clinical and administrative staff.

Makes clinical judgments and draws conclusions from collected data to identify patient care issues/trends that require intervention to improve patient care and/or obviate risk situations. Communicates findings and analysis to appropriate disciplines for action as indicated.

Initiates changes in clinical practice and/or the system for delivering patient care based on current concepts and findings from research and/or studies.

Works with medical center staff to ensure continued accreditation readiness (e.g., Joint Commission, CARF, OIG, and other accrediting bodies).

VA offers a comprehensive total rewards package: VA Nurse Total Rewards

Pay: Competitive salary, regular salary increases, potential for performance awards
Paid Time Off: 50 days of paid time off per year (26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year)
Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA
Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement)
Licensure: 1 full and unrestricted license from any US State or territory

Work Schedule: 6:30 am - 3:00 pm, TBD
Telework: Ad-hoc only
Virtual: This is not a virtual position.
Relocation/Recruitment Incentives: Not Authorized
Permanent Change of Station (PCS): Not Authorized

Major Duties:

The RN Quality Management Consultant (QARN) demonstrates leadership, experience, and creative approaches to improvement in quality-of-care outcomes. The QM Consultant demonstrates performance and leadership that is broad enough to improve the care for a group of patients. The QM Consultant is responsible for the documented outcomes at the program or service level. Program or service level outcomes must be broad and complex and can be demonstrated at any organizational level within a facility. Program is defined as a substantial coordinated group of activities impacting patients and/or employees.

The QM Consultant is assigned responsibility for their assigned quality management program area activities for the Medical Center and all off-site locations. The QM Consultant collects data, monitors staff compliance with relevant policies, directives, and standards, provides reports detailing trends, and provides direct staff support to all services in planning, designing, integrating, implementing, modifying, and administering, a comprehensive quality management program area. They participate in several facility councils, committees, and workgroups.

Executes the position responsibilities that demonstrate effective leadership, detailed planning, professional communication, creative and innovative approaches to the improvement of safety/healthcare program development and possess an ability to organize priorities. The QM
Consultant works in concert with leaders and others to sustain a culture of safety, modeling High Reliability Organization (HRO) practices.

The QM Consultant performs duties directly contributing to high quality and safe patient care within the Veterans Health Administration (VHA). Duties require the ability to apply specialized principles and practices to ensure a systems approach to healthcare delivery. The QM Consultant directly supports facility leadership in areas of planning, organization, development, direction, and evaluation of the quality program within the facility.

Assumes a leadership role in the assessment and evaluation of data collected through the screening activities and available data sources and compiles and presents data using Microsoft and other available quality tools in a usable form for all clinical and administrative staff.

Makes clinical judgments and draws conclusions from collected data to identify patient care issues/trends that require intervention to improve patient care and/or obviate risk situations. Communicates findings and analysis to appropriate disciplines for action as indicated.

Initiates changes in clinical practice and/or the system for delivering patient care based on current concepts and findings from research and/or studies.

Works with medical center staff to ensure continued accreditation readiness (e.g., Joint Commission, CARF, OIG, and other accrediting bodies).

VA offers a comprehensive total rewards package: VA Nurse Total Rewards

Pay: Competitive salary, regular salary increases, potential for performance awards
Paid Time Off: 50 days of paid time off per year (26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year)
Retirement: Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA
Insurance: Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement)
Licensure: 1 full and unrestricted license from any US State or territory

Work Schedule: 6:30 am - 3:00 pm, TBD
Telework: Ad-hoc only
Virtual: This is not a virtual position.
Relocation/Recruitment Incentives: Not Authorize

About Us:

We are the independent expert in assurance and risk management. Driven by our purpose, to safeguard life, property, and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence.

As a trusted voice for many of the world’s most successful organizations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

About SCPA

We help our customers respond to the increased demand for trust and transparency around products, assets, supply chains, and ecosystems, driving the transformation of the assurance industry. Whether certifying products, sharing claims or optimizing and decarbonizing supply chains, DNV helps companies manage risks and realize their long-term strategic goals, improving ESG performance and generating lasting, sustainable results. Drawing on our wide technical and industry expertise, we work with companies worldwide to bridge trust gaps among consumers, producers and suppliers.

We are looking for a Senior assessor to drive the growth of our Product Assurance business. In this role you will be responsible for assessing, inspecting and testing equipment, components and systems to customer or project specifications, and international regulations or standards like PED, CPR (steel), MD, EN 1090, ISO 3834, Welding standards, etc. In this position you will have a chance to interact with customers both external and internal, and actively participate in the section's effort towards efficiency and digitalization.

About the Role:

Responsibilities include:

• Proactive selling of our services across all domains of the business in South East Asia (SEA)
• Manage, perform, and deliver product certification and inspection activities
• Assist in preparation of customer proposals
• Provide technical guidance to customers and scoping the project with customers
• Project planning
• Complete end to end execution of the project in a timely manner with high quality.

About You:

• Graduate in Mechanical / Metallurgy engineering with 10+ years of experience in manufacturing industry.
• Qualified ISO9001 LA and IWE / IWT essential
• Experience of working with Certification or Notified Body of International Repute desirable.
• Sound Marketing Intelligence in the Inspection and Product Certification domain.
• Qualification as per PED /CPR/ ISO 3834 desirable.
• Qualified Level II for various NDE techniques.
• Sound knowledge of ASME, ASTM, EN and other related standards
• Familiar with manufacturing processes and knowledge of stage wise and final inspection of fabrication equipment, structural component, pipes, tubes, casting, forging and various mechanical component.
• Prior experience in executing small to large third party Inspections of Infrastructure, Mechanical, Electrical & Instrumentation, Civil, projects stretched over periods / months, successfully.
• Prior experience in leading Project kick-off meets, project document reviews, ITP/ QA Plan approvals, Construction procedure approvals, document MOMs, others as appropriate.
• ISO 17020/ ISO 9001 and related management systems exposure desirable. Preferably a QMS Auditor enabling vendor audits/ assessments.
• Safety conscious and enforce safe work practices.
• Good written and communication skills
• Able to work independently and in a team with good initiative
• Ability to interact and cooperate across other cultures.

Skills include:

• Sound Technical Knowledge
• Problem solving approach.
• Customer centric and managing a good customer relationship.
• Timely delivery of projects with high quality standard.

What we Offer:

• Flexible work arrangements for better work-life balance.
• Guaranteed Annual Wage Supplement.
• Generous Paid Leaves (Annual, Compassionate, Marriage, Maternity, Paternity & shared parental leave, Adoption leave, Childcare & Extended Childcare Leave, Examination leaves, National Service (NS) leave, medical leave, Prolonged Illness leave).
• Medical benefits (Clinical treatment, Emergency Medical Services, Specialist Consultation, Paediatrician Consultation, Inoculations (Hepatitis, H1N1 & Flu), Dental Treatment, Annual Medical Examination, Hospitalization & Surgical Benefits).
• Maternity Benefits.
• Pension and Insurance Policies (Central Provident Fund, Group Term Life Assurance, Group Personal Accident Insurance, Travel Insurance, Work Injury Compensation Insurance).
• Training and Development Assistance (Training Sponsorship, On-The-Job Training, Training Programme).
• Additional Benefits (Long Service Awards, Professional Membership, Gym Subsidy, Mobile Phone Reimbursement).
• Company bonus/Profit share.

*Benefits may vary based on position, tenure/contract/grade level*

DNV is an Equal Opportunity Employer and gives consideration for employment to qualified applicants without regard to gender, religion, race, national or ethnic origin, cultural background, social group, disability, sexual orientation, gender identity, marital status, age or political opinion. Diversity is fundamental to our culture and we invite you to be part of this diversity.

Key Responsibilities:

The Inventory Controller will be the key contact point of products and supplies count, ensuring that inventory remains balanced, restocks supplies, assists in maintaining inventory records, and provides customer assistance as necessary. The incumbent is expected to investigate and provide understanding on any variances found during either daily cycle count, month-end system matching count or year-end PI count, monitor on materials shelf life in stock before the materials expiry and follow warehouse SOP and safety aspects of warehouse operation.

Job description:

· Organize, monitors and maintains warehouse inventory level; processes purchasing orders as required; tracks orders and investigates problems

· Records purchases, maintains database, performs physical count of inventory, and reconciles actual stock count to computer-generated reports

· Supervise Logistics Admin Staff.

· Contribute to process optimization and ensure efficiency in warehouse operations

· Maintain accurate, complete and authenticity warehouse records

· Conduct stocktake/inventory stock count

· Monitor and validate all inventories, perform cycle count of all products and perform monthly short dated checks.

· Follow SOPs and best practices in the warehouse

· Ensure timely operations (shipment delivery) execution

· Work with internal and external stakeholders to ensure efficient flow of all shipments and manage inventory of all products on monthly and annual basis.

· Assist the Warehouse Manager in the implementation of projects and ad hoc logistics requirements

· Processes and documents return as required following established procedures.

· Any other ad-hoc duties as assigned and required

Key Qualifications

· Diploma in Logistics/Supply Chain, or any related field

· Possess at least 1 year of relevant experience

· Able to work in a fast pace environment

· Good analytical and logistical thinking abilities.

· Strong written and verbal communication skills.

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