Senior Quality Control Lead — Medical Devices

Nordson Industrial Coating Systems; Allen (TX); Vor Ort; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Nordson Medical – Surgical Solutions is seeking a hands-on Quality Control Supervisor to lead daily inspection and testing in a regulated medical device environment. You will supervise QC Technicians, support production priorities, and ensure compliance with FDA requirements and ISO 13485.

You will partner with Quality, Operations, and Engineering to address nonconformances, manage calibration programs, and drive improvements in measurement systems and environmental monitoring.

Qualifikationen

• Five years of quality experience in medical device manufacturing, including cleanroom operations.
• Three years of supervisory experience.
• Working knowledge of FDA Quality System requirements, ISO 13485, GMP practices, inspection methods, and calibration.
• Strong leadership, communication, organization, and problem-solving skills.

Aufgaben

• Lead, train, schedule, and develop Quality Control and Calibration Technicians.
• Oversee incoming, in-process, and finished-goods inspection and testing.
• Ensure inspection records and quality documentation are accurate, complete, and compliant.
• Partner with Quality, Operations, and Engineering to investigate and resolve nonconformances.
• Manage the calibration program and support measurement-system improvements.
• Monitor environmental monitoring and particle-count activities, including data review and trend reporting.
• Coordinate cycle counts, inventory reconciliation, quality holds, and related ERP transactions.
• Support new-product introduction, process improvements, yield improvement, and manufacturability initiatives.
• Reinforce safety, attendance, and company policy expectations.
• Provide hands‑on inspection support when needed to meet business priorities.

Kenntnisse

Leadership

Communication

Problem-solving

Quality assurance

Regulatory compliance

Ausbildung

High School Diploma

Associate or Bachelor’s in Science

Jobbeschreibung

Nordson Medical – Surgical Solutions is seeking a hands-on Quality Control Supervisor to lead daily inspection and testing in a regulated medical device environment. You will supervise QC Technicians, support production priorities, and ensure compliance with FDA requirements and ISO 13485.

You will partner with Quality, Operations, and Engineering to address nonconformances, manage calibration programs, and drive improvements in measurement systems and environmental monitoring.