Sr. Quality Engineer
Posted on :
18-11-2022
Employer Active
1 Vacancy
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Job Description
Req ID : 1689326
Responsibilities:
- The individual will be responsible to help update DHF and technical files to be EU MDR compliant and meet all Design Control and Risk Management requirements by following applicable safety, quality, regulatory procedures and processes to develop safe medical device. Works with Cross-Functional teams effectively to support EU MDR product certification submissions.
- 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 labelling 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 medical device industry.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
Employment Type
Full Time
Key Skills
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