Quality Control Leader — Medical Device Manufacturing

Regulatory Jobs; California; Vor Ort; USD 112.000 - 145.000; Vollzeit

Zusammenfassung

iRhythm Technologies is hiring a Quality Control Manager in Orange County to lead QC execution across manufacturing and receiving operations, ensuring robust inspection, documentation, material control, and disposition activities.

You will direct Manufacturing Quality Inspectors and Receiving Inspection teams, drive continuous improvement, and ensure compliance with ISO 13485 and FDA 21 CFR 820, while enabling scalable production and a strong quality culture.

Qualifikationen

• Bachelor's degree in Life Sciences, Engineering, or related discipline required; Master’s preferred.
• Minimum 8 years in a medical device manufacturing QC environment.
• Strong knowledge of ISO 13485 and FDA 21 CFR 820 requirements.
• Experience with MRB, deviations, and batch records.
• Proven leadership and cross-functional collaboration abilities.

Aufgaben

• Lead, coach, and develop QC Inspectors and Receiving Inspection personnel.
• Oversee inspection plans, sampling, and control plans with cross‑functional teams.
• Identify nonconformances, execute dispositions, and support MRB activities.
• Ensure GDP and documentation accuracy across records and travelers.
• Review batch records and travelers for completeness prior to release.
• Oversee Receiving Inspection and FAI activities per plan.
• Support calibration, maintenance, and equipment readiness for QC.
• Ensure compliance with ISO 13485 and FDA 21 CFR 820 and drive improvements.

Kenntnisse

Leadership

Quality inspection

Documentation control

GDP compliance

Data analysis

Cross-functional collaboration

Ausbildung

Bachelor's degree in Life Sciences, Engineering, or related technical discipline

Master’s degree preferred

Tools

ISO 13485 knowledge

FDA 21 CFR 820 knowledge

EU MDR familiarity

Jobbeschreibung

iRhythm Technologies is hiring a Quality Control Manager in Orange County to lead QC execution across manufacturing and receiving operations, ensuring robust inspection, documentation, material control, and disposition activities.

You will direct Manufacturing Quality Inspectors and Receiving Inspection teams, drive continuous improvement, and ensure compliance with ISO 13485 and FDA 21 CFR 820, while enabling scalable production and a strong quality culture.