Senior Quality Manager, Medical Devices (Contract Manufacturing)

Cadence, Inc.; Cranberry Township (Butler County); Vor Ort; USD 110.000 - 150.000; Vollzeit

Zusammenfassung

Cadence, Inc. in Cranberry Township, PA, is seeking an experienced Quality Manager to lead the Quality function at our growing finished medical device contract manufacturing site.

You will mentor the Quality team, ensure compliance with FDA regulations and ISO 13485, drive CAPA and internal audits, support customer audits, and collaborate with Manufacturing and Engineering to sustain operational excellence and patient-focused quality.

Qualifikationen

• Bachelor's degree in Engineering, Quality or related technical field.
• 5+ years of progressive quality leadership in regulated manufacturing (medical device/pharma preferred).
• Strong knowledge of FDA regulations and ISO 13485 compliance.
• Experience leading audits (customer, FDA, or notified body).

Aufgaben

• Lead, develop, and mentor the site Quality team.
• Ensure compliance with FDA regulations, ISO standards, and customer requirements.
• Maintain and improve the site's QMS including CAPA, NCRs, and audits.
• Oversee validation activities (IQ/OQ/PQ, process validation, equipment qualification).
• Prepare for customer audits and regulatory inspections; drive corrective actions.
• Collaborate with Manufacturing and Engineering to resolve quality issues.

Kenntnisse

Quality leadership

Cross-functional leadership

Problem solving

Statistical analysis

Root cause analysis

Continuous improvement

Regulatory knowledge

Ausbildung

Bachelor's in Engineering

Regulatory training

Jobbeschreibung

Cadence, Inc. in Cranberry Township, PA, is seeking an experienced Quality Manager to lead the Quality function at our growing finished medical device contract manufacturing site.

You will mentor the Quality team, ensure compliance with FDA regulations and ISO 13485, drive CAPA and internal audits, support customer audits, and collaborate with Manufacturing and Engineering to sustain operational excellence and patient-focused quality.