Sr. Quality Control Inspector
About The Position
We're looking for a Sr. Quality Control Inspector to join our mission-driven Quality team. In this role, you'll be responsible for performing inspections of components, subassemblies, and finished medical devices to ensure compliance with quality standards and regulatory requirements. This includes conducting quality checks, performance tests, reviewing documentation, and verifying Device History Records (DHR) for product release in accordance with the medical device Quality Management System (QMS).
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
- Equity participation as approved by Board of Directors (4-year vesting schedule)
- Comprehensive health, dental, and vision insurance plans
- Generous PTO and holiday schedule
- 401(k) retirement plan with company match
- Employee wellness initiatives and mental health support
- Collaborative and inclusive company culture focused on impact and innovation
- Opportunities for career growth and internal mobility
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Industry
Merchant Wholesalers, Durable Goods
Education Level
High school or GED
Number of Employees
501-1,000 employees
