Quality Control Manager (Medical Devices)

Location: Orange County, California, United States

Salary: $112,000–$145,000 per year

Company

hirify.global is a digital healthcare company developing wearable biosensors, cloud-based data analytics, and proprietary algorithms for cardiac health monitoring.

What you will do

• Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel.
• Execute and improve in-process, final, receiving, and first article inspections in collaboration with Quality Engineering, Supplier Quality, and Manufacturing Engineering.
• Manage nonconforming material, MRB activities, planned deviations, containment actions, and disposition documentation.
• Own batch record and traveler review, verifying inspection results, testing, traceability, approvals, and documentation completeness before lot release or handoff.
• Oversee calibration, preventive maintenance, and quality impact assessments for inspection and manufacturing equipment.
• Support audits and regulatory inspections while driving Gemba-based continuous improvement and monitoring quality metrics.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or a related technical discipline is required; a Master’s degree is preferred.
• At least 8 years of progressive experience in medical device manufacturing, quality control, inspection, or manufacturing quality operations.
• Strong working knowledge of ISO 13485 and FDA 21 CFR Part 820, with familiarity with EU MDD and EU MDR requirements.
• Experience investigating and resolving complex quality issues, including nonconformances, MRB activities, deviations, and corrective actions.
• Experience collaborating with Manufacturing, Quality Engineering, Supplier Quality, Engineering, Operations, and Facilities or Maintenance teams.
• Knowledge of statistical and quality tools, medical device risk management, process FMEAs, and ISO 14971 principles.

Nice to have

• Master’s degree in a relevant technical discipline.
• Experience training, mentoring, and developing quality control inspectors and quality personnel.
• An empathetic, collaborative, and accountability-driven leadership style.

Culture & Benefits

• Patient-focused work improving cardiac health solutions.
• Opportunity to contribute to manufacturing growth while maintaining product quality and regulatory compliance.
• Inclusive workforce welcoming diverse backgrounds, experiences, skills, and perspectives.
• Reasonable accommodations are available for qualified individuals with disabilities during the application process.