What You'll Do

• 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

What You'll Need

Minimum Qualifications

• High school diploma or equivalent

• 2 years of production experience in a regulated environment.

Preferred Qualifications

• 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.