Design Quality Engineer - Medical Devices

We are looking for a Design or Development Quality Engineer who will manage the key MDR program through consistent excellence in project management.

Responsibilities:

- Design Quality team member focused on life cycle management activities.
- Enhance the DESIGN CONTROL AND RISK MANAGEMENT processes to better reflect state of the art practices and drive continuous improvement.
- Apply STATISTICAL METHODS AND PROCESS/DESIGN EXCELLENCE TOOLS to establish test plans as well as evaluate test data and processes. Perform GAGE R&R STUDIES.
- Conduct and lead DESIGN VERIFICATION AND VALIDATION ACTIVITIES.
- Conduct and lead DESIGN/PROCESS FAILURE MODE EFFECTS AND ANALYSIS.
- Provide leadership in all areas of the QUALITY SYSTEM, including, but not limited to CORRECTIVE & PREVENTIVE ACTIONS, COMPLAINTS, NONCONFORMING MATERIALS, RISK MANAGEMENT, etc.
- Provide leadership in the understanding of medical device regulations to other disciplines.
- Communicate effectively at all levels within Quality as well as cross functionally with departments such as Product Development, Regulatory Affairs, Manufacturing, and Marketing.

Requirements:

- BSc in Engineering or related scientific discipline
- Several years of experience in related field
- Working knowledge of Design Controls, GMPs, QSR, 21 CFR 820, MDD 93/42/EEC, ISO13485 and ISO14971 quality requirements is required.
- Previous Quality Engineering experience is preferred.
- Strong quality engineering skills with a proven track record in design verification/validation, process verification/validation, and design/process Failure Mode and Effects Analysis.
- Working knowledge of material science and mechanical product knowledge is preferred.
- Development and manufacturing experience is preferred.

Kontakt: Luchele Mendes

Michael Bailey International is acting as an Employment Business in relation to this vacancy.