Quality Control Manager (Medical Devices)

TL;DR

Quality Control Manager (Medical Devices): Leading quality control execution across manufacturing and receiving operations with an accent on inspection plans, documentation control, material traceability, and regulatory compliance. Focus on driving inspection efficiency, nonconformance management, batch record verification, and continuous improvement initiatives.

Location: Orange County, CA (onsite)

Salary: $112,000 - $145,000

Company

Leading digital healthcare company creating wearable biosensors and cloud-based analytics for cardiac health monitoring.

What you will do

• Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection teams, ensuring training and accountability for inspection accuracy and documentation.
• Develop and improve inspection plans, sampling strategies, and control plans in collaboration with engineering teams to support efficient manufacturing.
• Manage nonconforming materials, Material Review Board activities, planned deviations, and ensure proper documentation in work orders and batch records.
• Oversee material identification, traceability, segregation, and enforce Good Documentation Practices across all records.
• Review and verify manufacturing batch records and travelers for completeness, accuracy, compliance, and traceability before lot release.
• Support receiving inspection, equipment calibration/maintenance, compliance audits, and lead Gemba walks for continuous improvement.

Requirements

• Bachelor’s Degree in Life Sciences, Engineering, or related field (Master’s preferred)
• Minimum 8 years in medical device manufacturing with quality control/inspection responsibility
• Strong knowledge of ISO 13485, FDA 21 CFR 820, EU MDD/MDR
• Experience with nonconformances, MRB, deviations, corrective actions, and cross-functional collaboration
• Proficiency in statistical tools (Cp/Cpk, Gage R&R), risk management (ISO 14971), and GDP
• Excellent communication skills and attention to detail

Nice to have

• Highly organized with ability to manage priorities in fast-paced environment
• Empathetic leadership style with experience in training and mentoring QC personnel

Culture & Benefits

• Growth opportunities in a rapidly expanding company focused on cardiac health innovation
• Collaborative environment valuing problem-solving, big thinking, and patient impact
• Inclusive workforce with equal opportunity employment practices
• Reasonable accommodations for disabilities