Posted on 06 Jul 2026

Quality Control Manager

West Chester, PA
Permanent
$125,000 - $135,000

About the Company

Our client is a global medical device company exclusively focused on cervical and lumbar spinal disease, with a market-leading total disc replacement (TDR) technology platform. Their flagship platform is one of the most studied and clinically validated TDR systems in the world, supported by hundreds of peer-reviewed publications and used in hundreds of thousands of implantations to date. The platform is differentiated by motion-preserving, anatomically tailored solutions that allow surgeons to math the implant to each patient's anatomy across both the cervical and lumbar spine. 

About the Role

We are looking for a Quality Control (QC) Manager to take ownership of inspection and release activities across incoming materials, in-process components, and finished medical devices. The successful candidate will lead a team of QC inspectors, technicians, and specialists; maintain a compliant, audit-ready quality system; and drive continuous improvement to support consistent product release and operational performance. 

This is a hands-on leadership role with significant cross-functional exposure across Manufacturing, Engineering, Quality Assurance, and Regulatory. The role is 100% on-site at the company's West Chester, PA corporate office and reports directly to the Vice President, Clinical, Regulatory and Quality Affairs. 

Key Responsibilities

Leadership & Team Management

  • Partner with the QC Supervisor to mentor, coach, and develop inspectors, technicians, and specialists.
  • Set clear performance expectations, deliver feedback, and conduct formal performance reviews.
  • Manage staffing levels, schedules, and workload distribution to meet production demand.
  • Foster a culture grounded in quality, accountability, and ongoing learning. 

Quality Control Operations

  • Design, implement, and continuously refine QC processes, procedures, and inspection workflows.
  • Oversee inspection of incoming materials, in-process assemblies, and finished devices.
  • Ensure sampling plans, test methods, and inspection procedures are properly defined and executed.
  • Review and approve Device History Records (DHRs) and other QC documentation.
  • Drive timely product disposition decisions to support production and shipment commitments.
  • Track and analyze quality performance data, and report results to senior leadership.
  • Partner with other functions to resolve quality issues at the source.

Regulatory and Quality System Compliance

  • Maintain compliance with FDA 21 CFR Part 820, ISO 13485, and other applicable international regulations.
  • Keep QC procedures, work instructions, and forms accurate, current, and under document control.
  • Support internal and external audits, including FDA, Notified Body, supplier, and customer audits.
  • Ensure calibration and preventive maintenance programs for QC equipment are robust and effective. 

Nonconformance Management & CAPA Support

  • Oversee identification, documentation, and evaluation of nonconforming product.
  • Work with Manufacturing, Engineering, and Quality Assurance to determine root cause and corrective actions.
  • Ensure containment, rework and scrap activities are executed in line with procedure.
  • Provide subject-matter input into CAPA investigations and effectiveness checks. 

Continuous Improvement

  • Analyze quality data to identify trends in defects, scrap, and process variation.
  • Lead initiatives to streamline inspection, reduce error rates, and improve throughput.
  • Apply statistical methods and tools (SPC, process capability) to strengthen the QC strategy.
  • Support lean manufacturing and Six Sigma projects across the operation. 

Equipment, Tools & Data Management

  • Oversee maintenance and calibration of measurement and test equipment used in QC.
  • Ensure measurement systems are validated (MSA/Gage R&R).
  • Manage QC documentation, logs, and inspection records in electronic and paper-based systems.
  • Use dashboards, metrics, and quality reports to drive data-led decisions. 

What You Will Bring

Required

  • Bachelor's degree in Engineering, Science, or a related technical discipline.
  • 5+ years of Quality Control or Quality Assurance experience in medical device manufacturing.
  • 2+ years of supervisory or management experience leading QC or QA teams.
  • Strong working knowledge of FDA QSR, ISO 13485, ISO 14971, and GMP principles.
  • Hands-on expertise in QC inspection techniques, measurement tools, and test equipment.
  • Proficiency with statistical tools (SPC, capability studies, MSA) and data analysis.
  • Experience with electronic QMS, ERP, and DHR systems.
  • Solid understandin of risk management and validation requirements.
  • Strong leadership, communication, and coaching skills, with the ability to influence without authority.
  • Excellent problem-solving, analytical, and decision-making skills, and the ability to manage competing priorities in a fast-paced environment. 

Preferred

  • Advanced degree or professional certification such as ASQ CQE or CQM/OE.
  • Experience across both 510(k) and PMA product domains.

Physical & Work Environment

  • Ability to sit or stand for extended periods.
  • Occasional lifting of objects up to 25lbs.
  • Ability to work within cleanroom environments as required.

Whats on Offer

  • Competitive base salary in the $125k - $135k range, plus a 15% target annual bonus tied to corporate and individual goals.
  • Comprehensive medical, dental, vision, life, and disability coverage, effective from day one of employment.
  • Voluntary benefit programs to support a range of work/life needs.
  • 10 vacation days (prorated by start date), 4 personal days, 6 sick days, and 2 floating holidays - frontloaded after the first payroll.
  • 8 company-paid holidays per year.
  • The chance to join a growing, mission-driven medical device organization focused on improving patient outcomes. 

This description outlines the general nature and level of work expected of the role and is not an exhaustive list of duties or responsibilities. The scope of the role may evolve over time. The hiring company is an equal opportunity employer. 

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