Quality Engineer
Posted on :
07-10-2022
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Job Description
Responsibilities:
- Provides Quality compliance input to the project team for project deliverables (e.g., Product Specifications, Risk Files, Design Reviews, V&V, Design Transfer, Clinical Evaluation Plans/Reports, etc..) and demonstrating commitment to patient safety and product quality.
- Perform document reviews as Quality Reviewer to support EU MDR project activities such as design and labeling change controls.
- Utilizes engineering and quality tools/methodologies (e.g. Six Sigma-DMADV DMAIC,) to investigate complex and diverse product technical product problems and develop solutions which require critical, analytical, and creative thinking.
- Understanding and working experience with medical device industry quality requirements associated with product development, design control, and product risk management.
- Understanding and working knowledge of FDA regulation 21 CFR Part 820 and international regulations EN ISO13485 and EN ISO 14971
- Familiarity with Medical Device Directive (MDD)/Medical Device Regulation (MDR) requirements for design control and product risk management
- Strong communication skills (verbal and written) and team player
- BS in Engineering with preference in Mechanical, Biomedical, or Chemical Engineering.
- One to three years of Quality experience with preference in the medical device industry
Employment Type
Full Time
Key Skills
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