Quality Control Inspector
About The Position
Endologix LLC is seeking a temporary Quality Control Inspector to join its Quality team in Santa Rosa, California. The role inspects components, subassemblies, and finished medical devices to ensure they meet quality standards and regulatory requirements. Work includes quality checks, performance testing, documentation review, and verification of Device History Records (DHR) for product release under the medical device Quality Management System (QMS). The inspector works in a cleanroom and follows established procedures, documentation practices, and safety protocols. The position also involves monitoring temperature and particle counts, processing transactions in QAD ERP and MES applications, and managing multiple tasks in a fast-paced manufacturing environment.
Requirements
- High school diploma or equivalent.
- 1–5 years of Quality Control experience.
- Ability to understand and follow technical procedures, work instructions, and basic specifications related to product and component inspection.
- Ability to identify relevant information in technical drawings and documents and report discrepancies to the supervisor.
- Familiarity with applicable quality standards and willingness to learn specific regulations under supervision.
- Mechanical aptitude and working knowledge of measurement instruments.
- Strong written and verbal communication skills for reports, correspondence, and presentations.
- Mathematical proficiency in fractions, percentages, ratios, and proportions.
- Problem-solving skills and ability to work cross-functionally and manage multiple priorities.
Nice To Haves
- Quality Control experience in the medical device industry.
Responsibilities
- Perform audits, inspections, configuration checks, and functional testing to ensure product quality and compliance with established procedures.
- Review and verify lot history records for completeness, accuracy, and adherence to SOPs; investigate records related to customer experience reports.
- Inspect subassemblies, finished products, purchased components, and tools using defined criteria and standard measurement techniques.
- Conduct rework on subassemblies or finished goods as required.
- Document inspection and testing results in accordance with Good Documentation Practices (GDP).
- Review Device History Records (DHR) for compliance with established procedures and GDP requirements.
- Identify quality issues and recommend corrective actions or process improvements.
- Perform product testing to confirm conformance to quality standards.
- Work in a cleanroom while following protocols and safety requirements.
- Perform temperature and particle-count monitoring and manage ERP (QAD) and MES application transactions.
- Perform other duties as assigned by the supervisor.
- Demonstrate punctuality, reliability, and a strong work ethic.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
