As a Design Quality Engineer, you will be ensuring that the design control requirements are fulfilled as part of PDP and CDP projects team
- You will manage the risk management activities from the early stages of the development process and throughout the product lifecycle.
- You will review and approve product Verification and Validation strategy
- You will review and approve design documents and processes in accordance with Design Controls standards and company’s policies.
- You will track product Standards to guide others on their correct implementation.
- You will Implement statistical tools usage in R&D, e.g. Cpk, MSA, DOE.
- BSc Engineering degree or higher
- At least 2 years prior experience related to design quality in a medical device company
- Working knowledge of the FDA Quality System Regulation 21CFR 820, 21CFR Part11, ISO13485, ISO14971 and the Medical Device Directive
- Experience in risk evaluation techniques, e.g. FMEA, fault tree analysis
- Reliability analysis and test methods
- Working knowledge of software and electrical medical devices related standards, IEC62304, IEC 60601, usability and human factors standards
- Demonstrated scientific analysis abilities
- 6 sigma Certificate is an advantage