Medical Device Quality Assurance EngineerPEAK Technical Staffing • Fairfield, NJ, US
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Medical Device Quality Assurance Engineer
PEAK Technical Staffing • Fairfield, NJ, US
4 days ago
Job type
- Full-time
Job descriptionAssist in implementing Corrective Action Plans Update Medical Device Risk Management documentation Support Post Market Surveillance activities Update product Technical Files Update Clinical Evaluation Reports Create, update Quality Assurance Instructions and Procedures Any additional Quality / Regulatory activity required consistent with assuring a compliant Quality Management System Knowledge of the following areas in Quality : Corrective Action (CAPA), Technical File Documentation, Risk Management, Clinical Evaluation, Post Market Surveillance
Medical Device Quality Assurance Engineer
Supports Quality Assurance and Regulatory in activities that ensure compliance with and international regulations, standards, and guidance related to Class II medical devices.
Requirements
- Minimum of a Bachelor's degree. A Bachelor's degree in Regulatory Affairs or scientific discipline, highly preferred
- Knowledgeable in EU MDR, CFR Part , CFR Part , ISO , ISO .
- Quality or Regulatory experience in Medical Device industry
- Attention to detail
- Technical writing skills
- Ability to adjust to changing priorities and assignments
Responsibilities
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Quality Assurance Engineer • Fairfield, NJ, US