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Quality Control Manager
Job in
Jacksonville, Duval County, Florida, 32099, USA
Listed on 2026-11-05
Listing for:
El Camino Health
Full Time
position Listed on 2026-11-05
Job specializations:
-
Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Regulatory Compliance Specialist, Production QC/QA, Quality Engineering
Job Description & How to Apply Below
About This Role
The Quality Control Manager leads Quality Control execution across Manufacturing and Receiving operations, driving inspection, documentation, material control, and disposition activities. The role manages Manufacturing Quality Inspectors and Receiving Inspection teams, ensuring compliance with regulatory requirements and internal procedures while enabling efficient production through robust inspection plans, nonconformance and deviation management, and continuous improvement.
What You Will Be Doing- Lead, coach, and develop Manufacturing Quality Inspectors and Receiving Inspection personnel.
- Ensure inspectors are trained, qualified, and accountable for inspection accuracy, documentation integrity, and timely escalation of quality issues.
- Develop and continuously improve inspection plans, sampling strategies, and control plans in collaboration with Quality Engineering and Supplier Quality.
- Ensure effective in-process, final, and receiving inspections are executed according to approved plans and work instructions.
- Drive improvements to inspection efficiency, first-pass yield, and defect containment.
- Identify, document, and contain nonconforming material in manufacturing and receiving.
- Participate in Material Review Board activities, ensuring accurate disposition execution and documentation.
- Support planned deviations to maintain production continuity while completing risk assessments and approvals.
- Record all dispositions, deviations, and containment actions accurately in work orders, travelers, and batch records.
- Ensure proper material identification, segregation, labeling, and traceability from receiving through manufacturing and final disposition.
- Enforce Good Documentation Practices across inspection records, batch records, travelers, RI/DAI records, and disposition documentation.
- Review, verify, and accept manufacturing batch records and travelers for completeness and compliance prior to lot release.
- Identify documentation errors and trends during batch record review and ensure timely correction.
- Oversee execution of Receiving Inspection and First Article Inspection activities per approved sampling plans and inspection criteria.
- Ensure accuracy, completeness, and traceability of RI and FAI records.
- Collaborate with Supplier Quality to document and address supplier-related quality issues.
Calibration, PM & Maintenance Support
- Support calibration and preventive maintenance programs for inspection and manufacturing equipment.
- Ensure equipment is calibrated, maintained, and fit for purpose before release for production or inspection.
- Support corrective maintenance activities, ensuring quality impact assessments, documentation updates, and effectiveness verification.
- Ensure QC operations comply with ISO 13485, QSMR/FDA 21 CFR 820 and applicable internal SOPs.
- 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.
- Lead continuous improvement initiatives within Quality Control, including monthly Gemba walks focusing 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.
- Bachelor’s Degree in Life Sciences, Engineering, or a related technical discipline (Master’s preferred).
- Minimum of 8 years of progressive experience in a medical device manufacturing environment, with responsibility for quality control or manufacturing quality operations.
- Strong working knowledge of ISO 13485, FDA 21 CFR Parts 820, EU MDD, and EU MDR requirements.
- Experience resolving complex quality and manufacturing issues, including nonconformances, MRB activities, deviations, and corrective actions.
- Proven collaboration with Manufacturing, Quality Engineering, Supplier Quality, Engineering, Operations, and Facilities/Maintenance teams.
- High attention to detail, data accuracy, and GDP compliance.
- Excellent verbal and written…
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