Quality Assurance Engineer I

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 institution

• Experience in the medical device industry (21 CFR 820 or ISO 13485); internships or project work in quality, manufacturing, or product development preferred

Key Competencies

• 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” mindset—unafraid to surface and address quality concerns

• Meticulous attention to detail, particularly with documentation

• Working knowledge of programming languages (Python, JavaScript, SQL, or Visual Basic) a plus

Why 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.