Sr. Quality Control Inspector
About The Position
Endologix LLC is seeking a Sr. Quality Control Inspector to join their mission-driven Quality team. This role involves performing inspections of components, subassemblies, and finished medical devices to ensure compliance with quality standards and regulatory requirements. The inspector will conduct quality checks, performance tests, review documentation, and verify Device History Records (DHR) for product release in accordance with the medical device Quality Management System (QMS). The company emphasizes a collaborative, purpose-driven culture focused on advancing patient care in vascular health.
Requirements
- High School Diploma or equivalent required.
- 3–6 years of Quality Control experience, preferably in the medical device industry.
- Mechanical aptitude and working knowledge of measurement instruments.
- Proficiency in Microsoft Excel and Word.
- Ability to read and interpret technical procedures, drawing, specifications, ASTM standards, and medical device regulatory requirements.
- Strong written and verbal communication skills for reports, correspondence, and presentations.
- Mathematical proficiency in probability, statistical inference, fractions, percentages, ratios, and proportions.
- Problem-solving skills with the ability to work in a cross-functional environment and manage multiple priorities.
- Experienced in using measuring equipment such as Microscope, CMM, Instron tester, calipers, pin gauge, micrometer, snap gauge etc.
Responsibilities
- Inspect purchased components, tooling, subassemblies, and finished products using defined criteria and standard physical, mechanical, and/or electrical measurements.
- Rework or reject subassemblies or finished products as necessary.
- Support process and system audits using established procedures as audit standards.
- Document inspection and testing results in compliance with Good Documentation Practices (GDP).
- Maintain controlled document files and test records accurately and promptly.
- Inspect test equipment and fixtures to support maintenance and calibration activities.
- Assist in writing and updating inspection procedures, protocols, and checklists.
- Evaluate issues and provide initial recommendations for corrective actions or system improvements to the supervisor.
- Participate in Non-Conforming Material Report (NCMR) management processes.
- Collaborate with production and quality teams to provide feedback on assembly accuracy and compliance.
- Review Device History Records and related documentation for adherence to procedures and GDP.
- Work within a cleanroom environment following all applicable protocols.
- Perform other duties as assigned by supervisor.
Benefits
- Competitive pay
- Solid benefits
- Career growth
- Hourly Rate of $26.44/hr-$30.64/hr
- Discretionary bonus
- Equity participation as approved by Board of Directors (4-year vesting schedule)
- Comprehensive health, dental, and vision insurance plans
- Flexible Health Savings Accounts (HSAs) and/or Flexible Spending Accounts (FSAs)
- Generous paid time off (vacation, sick leave, holidays, and flexible time off that is available for Exempt employees)
- 401(k) retirement plan with company match
- Employee wellness initiatives, mental health resources, and Employee Assistance Program (EAP)
- Employee recognition programs and awards
- Commuter benefits or transportation stipends
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
High school or GED
