About the Role
We're 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. You'll 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
- Administer supplier management processes
- 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
Qualifications
Minimum Requirements
Bachelor's degree in engineering (preferably Mechanical or Biomedical) from an accredited institutionExperience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality, manufacturing, or product development preferredKey Competencies
Ability to interpret technical drawings and specificationsStrong analytical thinking and problem-solving skillsExcellent verbal and written communicationComfortable working in a fast-paced, dynamic environmentProficient in Microsoft Word and ExcelStrong collaborator with a "do the right thing" mindset-unafraid to surface and address quality concernsMeticulous attention to detail, particularly with documentationWorking knowledge of programming languages (Python, JavaScript, SQL, or Visual Basic) a plusWhy Join Us?
This is a unique opportunity to grow your engineering career within a highly innovative medical device organization. You'll gain exposure across operations, quality systems, and continuous improvement while helping deliver life-changing solutions to our customers.