I am urgently recruiting for a motivated CSV Engineer to join the Quality Department of a renowned Medical Device Company in Groningen.
The site is responsible for the design and manufacture of vision care products. You will be part of a new exciting project to further develop IOL manufacturing technology with a high degree of automation.
- Provide technical expertise and guidance with regards to the computerized system lifecycle
- Provide independent Quality review and approval of CSV deliverables and ongoing GxP related change controls.
- Provide Quality and CSV oversight to ensure compliance with applicable regulatory requirements
- Ensure change control procedures are followed to maintain the system
- Manage and execute Periodic Reviews per schedules.
- Implement controls to ensure data integrity and traceability of Quality records.
- Support process validations (IQ/OQ/PQ) and test method validation, where needed.
- Identify critical areas for improvement and prioritize and execute the initiatives
- As needed, perform or support nonconformance / CAPA root cause investigations, defining action plans
- Act as a Subject Matter Expert during internal and external audits (e.g. Notified Body or FDA)
- At least 5 years of relevant work experience, preferably in automated processes within the pharmaceutical or medical device industry.
- At minimum a relevant Bachelor degree.
- Knowledge of and experience in Software Development Life Cycle processes, including: Requirements Definition (functional/ compliance/ non-functional), Design specifications, programming techniques, Risk based Testing approaches, and Risks and corresponding controls (software/ procedural).
- Working knowledge of computerized systems validation, validation of products/equipment/processes, statistics, risk management, change control, and data integrity.
- Working knowledge of relevant Medical Device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11, ISO 13485, ISO 14971, IEC 82304, IEC 62304, FDA guidelines for Software Validation).
- Familiar with implementing or applying Agile development processes.
- Excellent command of the English and preferably Dutch
- Duration: 1 year contract
- Start date: 1 Nov 2021 or ASAP
- Able to work both on and off site
- Location: Groningen
Please apply with your CV. For further information, please contact Aimee Brenner at +31 (0)20 20 44 502 or by email at firstname.lastname@example.org
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