About This Role:The Quality Control Manager is responsible for leading Quality Control execution across Manufacturing and Receiving operations, ensuring effective inspection, documentation, material control, and disposition activities. This role provides direct leadership to Manufacturing Quality Inspectors and Receiving Inspection teams and owns day-to-day quality control execution on the manufacturing floor.
The Quality Control Manager ensures compliance with applicable regulatory requirements and internal procedures while enabling efficient production through robust inspection plans, effective nonconformance and deviation management, and continuous improvement initiatives.
Why This Role Is Critical- Establishes clear ownership of shop-floor quality execution
- Reduces compliance and audit risk related to inspection, documentation, and material control
- Enables scalable manufacturing growth while maintaining product quality and regulatory compliance
- Strengthens quality culture through visible leadership and continuous improvement
What You Will Be Doing1. Quality Control Leadership & Execution- Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel.
- Ensure inspectors are trained, qualified to perform inspections and documentation per approved procedures.
- Establish clear expectations and accountability for inspection accuracy, documentation integrity, and timely escalation of quality issues.
2. Inspection Strategy & Manufacturing Quality Support- Support the development, implementation, and continuous improvement of inspection plans, sampling strategies, and control plans in collaboration with Quality Engineering, Supplier Quality and Manufacturing Engineering.
- Ensure effective in-process, final, and receiving inspections are executed in accordance with approved inspection plans and work instructions.
- Drive improvements to inspection efficiency, first-pass yield, and defect containment across manufacturing operations.
3. Nonconformance, MRB & Planned Deviation Support- Ensure timely identification, documentation, and containment of nonconforming material in manufacturing and receiving.
- Support and participate in Material Review Board (MRB) activities, ensuring accurate disposition execution and documentation.
- Support planned deviations to maintain production continuity while ensuring risk assessments, approvals, and documentation are completed per the Quality Management System.
- Ensure all dispositions, deviations, and containment actions are accurately reflected in work orders, travelers, and batch records.
4. Material Identification, Traceability & Documentation Control- Ensure proper material identification, segregation, labeling, and traceability from receiving through manufacturing and final disposition.
- Enforce Good Documentation Practices (GDP) across inspection records, batch records, travelers, RI/DAI records, and disposition documentation.
- Ensure work orders, travelers, and batch records are executed in compliance with approved procedures and instructions.
Batch Record Review- Own the review, verification, and acceptance of manufacturing batch records and travelers to ensure completeness, accuracy, and compliance prior to lot release or handoff.
- Verify that all required inspection results, testing reports, in-process checks, deviations, nonconformances, and MRB dispositions are properly documented and approved within the batch record or traveler.
- Ensure traceability is complete and intact, including material lots, subassemblies, equipment identification, and inspection status.
- Identify documentation errors, omissions, or trends during batch record review and ensure timely correction, escalation, and retraining as necessary.
- Partner with Manufacturing and Quality Engineering to improve batch record clarity, usability, and execution robustness.
5. Receiving Inspection Oversight- Oversee execution of Receiving Inspection and FAI activities per approved sampling plans and inspection criteria.
- Ensure accuracy, completeness, and traceability of RI and FAI records, including lot identification and acceptance status.
- Collaborate with Supplier Quality to ensure timely escalation and documentation of supplier-related quality issues.
6. Equipment Control: Calibration, PM & Maintenance Support- Support of calibration and preventive maintenance (PM) programs for inspection and manufacturing equipment used for product acceptance.
- Ensure equipment is calibrated, maintained, and suitable for its intended use prior to release for production or inspection.
- Support corrective maintenance activities by ensuring quality impact assessments are completed, documentation is updated, and effectiveness is verified following repairs or failures.
7. Compliance, Audit Support & Risk Management- Ensure QC operations comply with ISO 13485, QSMR/FDA 21 CFR 820 and applicable internal SOPs, DOP's and work instructions.
- Support internal audits, external audits, and regulatory inspections by demonstrating effective QC execution and control.
- Monitor QC-related metrics and trends to proactively identify compliance risks and improvement opportunities.
8. Continuous Improvement & Gemba Leadership- Own continuous improvement initiatives within Quality Control, including monthly Gemba walks focused on inspection effectiveness, material flow, documentation quality, and compliance.
- Use data, observations, and team feedback to identify systemic gaps and drive sustainable improvements.
- Partner with cross-functional teams to implement corrective and preventive improvements.
What We Want to See- Bachelor's Degree in Life Sciences, Engineering, or a related technical discipline is required; Master's Degree is preferred.
- Minimum of 8 years of progressive experience in a medical device manufacturing environment, with demonstrated responsibility for quality control, inspection, or manufacturing quality operations.
- Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820 , with working familiarity of EU MDD and EU MDR requirements.
- Demonstrated ability to identify, investigate, and resolve complex quality and manufacturing issues, including nonconformances, MRB activities, deviations, and corrective actions.
- Proven experience collaborating with Manufacturing, Quality Engineering, Supplier Quality, Engineering, Operations, and Facilities/Maintenance teams.
- High level of attention to detail, with strong focus on timeliness, data accuracy, and GDP compliance.
- Excellent verbal and written communication skills, with the ability to communicate expectations, risks, and decisions at all organizational levels.
- Working knowledge of statistical and quality tools, including trend analysis, process capability (Cp/Cpk, Pp/Ppk), Gage R&R, and defect trend analysis.
- Working knowledge of medical device risk management, including process FMEAs and alignment with ISO 14971 principles.
Ways to Stand Out
- Highly organized, with the ability to manage multiple priorities, balance production demands with compliance, and operate effectively in a fast-paced manufacturing environment.
- Demonstrated leadership style that is empathetic, collaborative, and accountability-driven, with experience coaching and developing QC inspectors and quality personnel.
- Experience providing training, mentoring, and development to strengthen inspection capability and consistency.
Location:Orange County
Actual compensation may vary depending on job-related factors including knowledge, skills, experience, and work location.
Estimated Pay Range$112,000.00 - $145,000.00
