Quality Control Technician II
About The Position
Serve as the quality subject matter expert for product and process quality standards. Ensure compliance with cGMPs and regulatory requirements (FDA, BSI, TUV, and other medical device agencies). Act as the first point of contact for daily production line quality issues. Investigate product and process concerns, identify root causes, and support corrective actions. Partner with Quality Engineers and cross-functional teams to reduce risk and improve processes. Deliver defect awareness and quality training to production associates. Support the management and disposition of non-conforming materials and products. Segregate and contain product when quality discrepancies are identified. Conduct audit readiness checks and support internal quality audits. Monitor, trend, and analyze key quality metrics and performance data. Review customer complaints and support timely investigations and resolutions. Assist in preparing quality reports and periodic reviews. Review calibration certificates and quality documentation. Perform basic microbiology sampling and testing. Communicate quality concerns, trends, and watchouts to manufacturing teams. Support Environmental Health & Safety (EHS) initiatives and report safety concerns. Maintain compliance with all site and corporate Quality Management System requirements. Provide support during equipment failures, process interruptions, shutdowns, and special projects.
Requirements
- High school diploma or equivalent
- 2 years of production experience in a regulated environment.
Nice To Haves
- 1–2 years of Quality Assurance or related experience.
- Degree or certificate in Engineering, Science, or Business.
- Understanding of GMP/cGMP-regulated manufacturing environments.
- Knowledge of statistics and quality tools.
Responsibilities
- Serve as the quality subject matter expert for product and process quality standards.
- Ensure compliance with cGMPs and regulatory requirements (FDA, BSI, TUV, and other medical device agencies).
- Act as the first point of contact for daily production line quality issues.
- Investigate product and process concerns, identify root causes, and support corrective actions.
- Partner with Quality Engineers and cross-functional teams to reduce risk and improve processes.
- Deliver defect awareness and quality training to production associates.
- Support the management and disposition of non-conforming materials and products.
- Segregate and contain product when quality discrepancies are identified.
- Conduct audit readiness checks and support internal quality audits.
- Monitor, trend, and analyze key quality metrics and performance data.
- Review customer complaints and support timely investigations and resolutions.
- Assist in preparing quality reports and periodic reviews.
- Review calibration certificates and quality documentation.
- Perform basic microbiology sampling and testing.
- Communicate quality concerns, trends, and watchouts to manufacturing teams.
- Support Environmental Health & Safety (EHS) initiatives and report safety concerns.
- Maintain compliance with all site and corporate Quality Management System requirements.
- Provide support during equipment failures, process interruptions, shutdowns, and special projects.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
