Johnson & Johnson
NL - Quality Assurance Engineer
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
Currently we are looking for Quality Assurance Engineers to expand our pool. On a regular basis we have Quality Assurance Engineering positions open in Groningen for Johnson & Johnson Vision!
If you are interested in working for Johnson & Johnson, do not hesitate to apply! Once you are in our pool, you will be the first person we contact when we have an open vacancy.
Johnson & Johnson Vision is committed to transforming the world's vision. We strive to raise awareness of the importance of vision and eye care and to deliver the best choices in vision correction in the world.
As a QA Engineer you will provide support for product and process development projects and the production process. As well as support in the implementation, improvement and development of the quality policy and the quality system in order to guarantee the quality of the products produced by AMO Groningen to guarantee goods.
Core tasks:
- Ensure quality assurance within product and process development projects.
- Perform and assess statistical analyzes and support the implementation of statistical process control techniques, sampling schemes and other quality techniques.
- Assess and (partly) determine specifications for raw materials and consumables, processes, semi-finished products and end products in relation to internal and external quality standards.
- (Co-)supervise external (including DEKRA/FDA) and internal audits (CQA).
- Write and review protocols and reports.
- Non-conformity management.
- Advise, review and (approve) changes in products/processes or systems, in line with the applicable procedures.
- Approving all QMS related procedures and work instructions.
- Compile and report metrics.
- Provide input to the Site Management Review.
- Continuous improvement of the focus area in response to regulatory developments, trends, deviations or other data-driven inputs.
Focus areas:
Within the QA Engineering group there are several areas to which the QA Engineers provide support. Specific assignments for the Quality Assurance Engineers within the specialization areas can be defined in the individual objectives.
- R&D/Technology:
- Ensuring quality assurance within product and process development projects - performing risk analyses:
- Write the risk management plan and report
- Write validation plans and reports
- Audite the Design History File
- Participate during Design Reviews
- Ensuring quality assurance within technology developments.
- Performing and assessing statistical analyzes and providing support in the implementation of statistical process control techniques, sampling schemes and other quality techniques.
- Assessing and (co) determining specifications for raw materials and consumables, processes, semi-finished products and end products in relation to internal and external quality standards.
- Review all changes to product specifications.
- Quality Systems:
- Management of the quality systems.
- Franchise procedures and regulatory standards roll-out.
- Metrics reporting.
- (Co-)supervising external (including DEKRA/FDA) and internal audits (CQA).
- Quality Operations:
- Addressing non-conformities within production and taking care of internal escalations.
- Supervising planned deviations from the production process.
- Advising, reviewing and (approving) changes in production processes, in line with the applicable procedures.
- Analyze data on rejects within the production process for continuous improvement and reduce or eliminate sources of variation within the production process.
- Complaint Handling:
- Ensure the preparation and implementation of the complaint handling process within AMO Groningen in accordance with JJSV procedures.
- •Reviewing and approving prepared complaint reports.
- Support in executive work with regard to complaints handling where necessary.
- Identifying and communicating to management of bottlenecks with regard to complaints handling; adjusting planning regarding complaints handling where necessary.
- Analyzing and monitoring trends in complaints, with which a possible structural deviation can be identified and corrected. Reporting trends to stakeholders.
- Computerized Systems Validation (CSV):
- Ensure the execution of activities related to Manufacturing Systems Development Life Cycle (SDLC) and systems compliance according to applicable regulations and procedures.
- Provide support related to the qualification of computerized systems ensuring that the validation approach, output and its documentation comply with applicable procedures.
- Granting permission for final release of the applications.
- Review / approve changes that require CSV approval to keep the CSV application in a validated state throughout its lifecycle.
- Conduct independent reviews of CSV related validation documentation.
Job Requirements:
- Master, Bachelor or HBO degree is prefered.
- Several years of relevant work experience, preferably in the pharmaceutical or medical-device industry.
- Knowledge of GMP, MDD/MDR, QSR CFR 820, ISO 13485, ISO 14971.
- Knowledge of quality-assurance systems (QMS).
- Knowledge of MS Office.
- Knowledge of validation of technical systems and processes.
- Knowledge of statistics and quality-improvement methods.
- Good communication skills.
- Flexibility and accuracy .
- Ability to work independently and as part of a team.
- Fluency in the Dutch and English language.
EXTRA INFORMATION:
- You will work on-site in Leiden.
- This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner YACHT. They can offer you a contract for the duration of the assignment at J&J, a one year contract or a freelance contract (ZZP).