Quality Control Manager

El Camino Health; Town of Florida (NY); On-site; USD 112,000 - 145,000; Full time

Job summary

El Camino Health is seeking a Quality Control Manager to oversee Quality Control execution across Manufacturing and Receiving operations. The role emphasizes compliance with regulatory requirements while fostering effective inspection practices.

Ideal candidates will have a Bachelor’s in Life Sciences or Engineering and 8+ years in medical device quality control. Strong leadership and collaborative skills are essential to drive improvements and maintain compliance.

Qualifications

• Minimum of 8 years of experience in medical device manufacturing related to quality control.
• Proven collaboration with cross-functional teams.
• Leadership experience in coaching and developing QC personnel.

Responsibilities

• Lead and develop Quality Control teams.
• Manage inspection strategies and ensure inspection integrity.
• Oversee nonconformance and material review activities.

Skills

Quality Control Leadership

Inspection Strategy

Nonconformance Management

Documentation Control

Continuous Improvement

Education

Bachelor’s Degree in Life Sciences or Engineering

Master’s Degree (preferred)

Tools

Statistical Quality Tools

ISO Standards Knowledge

Job description

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

1. Quality Control Leadership & Execution
   • 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.
2. Inspection Strategy & Manufacturing Quality Support
   • 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.
3. Nonconformance, MRB & Planned Deviation Support
   • 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.
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 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.
5. Receiving Inspection Oversight
   • 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.
6. Equipment Control: 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.
7. Compliance, Audit Support & Risk Management
   • 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.
8. Continuous Improvement & Gemba Leadership
   • 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.

What We Want to See

• 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 communication skills; able to communicate expectations and decisions at all levels.
• Working knowledge of statistical and quality tools (trend analysis, Cp/Cpk, Pp/Ppk, Gage R&R, defect trend analysis).
• Workings knowledge of medical device risk management, FMEAs, and ISO 14971 principles.
• Highly organized, capable of managing multiple priorities and balancing production demands with compliance.
• Leadership style that is empathetic, collaborative, and accountable; experience coaching and developing QC personnel.

Location: Orange County

Estimated Pay Range: $112,000.00 - $145,000.00

iRhythm Technologies, Inc. is an Equal Opportunity Employer. We will consider for employment all qualified applicants with arrest and conviction records in accordance with all applicable laws. iRhythm provides reasonable accommodations for qualified individuals with disabilities in job application procedures, including those who may have any difficulty using our online system.