Quality Assurance Engineer I
2 weeks ago
Current job opportunities are posted here as they become available.
About the RoleWere seeking a Quality Assurance Engineer I to support critical Quality Management System functions within our manufacturing operations. This role is ideal for an early career engineer looking to make an immediate impact in a fast?paced medical device environment. Youll help manage supplier quality, drive corrective actions, support compliance, and contribute to continuous improvement initiatives that directly influence patient outcomes.
Key Responsibilities- Support production teams on all manufacturing?related quality needs
- Coordinate equipment calibration and preventive maintenance tracking
- Manage CAPA documentation, follow?up, and closure
- Maintain training compliance records
- Enter and track customer complaints in accordance with regulatory requirements
- Support quality metrics reporting and system activity tracking
- Identify and implement process improvement opportunities
- Assist with documentation simplification, workflow charts, data analytics, and general administrative support
- Perform other quality engineering tasks as assigned
- Bachelors degree in engineering (preferably Mechanical or Biomedical) from an accredited institution
- Experience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality, manufacturing, or product development preferred
- Ability to interpret technical drawings and specifications
- Strong analytical thinking and problem?solving skills
- Excellent verbal and written communication
- Comfortable working in a fast?paced, dynamic environment
- Proficient in Microsoft Word and Excel
- Strong collaborator with a do the right thing mindsetunafraid to surface and address quality concerns
- Meticulous attention to detail, particularly with documentation
Why Join Us?
This is a unique opportunity to grow your engineering career within a highly innovative medical device organization. Youll gain exposure across operations, quality systems, and continuous improvement while helping deliver life?changing solutions to our customers.
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