Quality Control Manager

Quality Control Manager at ACE Partners Quality Control Manager at ACE Partners in West Chester, Pennsylvania Posted in about 22 hours ago.

Type:

full-time

Job Description:

Quality Control Manager Location:

Greater Philadelphia Area (Onsite)

Compensation:

$125,000-$135,000 base salary + annual bonus About the Opportunity A growing medical device company is seeking an experienced Quality Control Manager to lead quality control operations supporting the manufacture and release of regulated medical devices. This individual will oversee incoming, in-process, and finished product inspection activities while ensuring compliance with FDA, ISO, and GMP requirements. This is a hands-on leadership role ideal for someone passionate about quality systems, continuous improvement, and building high-performing teams in a fast-paced medical device environment. Key Responsibilities Leadership & Team Management Lead, mentor, and develop Quality Control inspectors and technicians Manage staffing, scheduling, and workload distribution Establish performance expectations and support employee development Promote a culture of accountability, compliance, and continuous improvement Quality Control Operations Oversee inspection of incoming materials, in-process assemblies, and finished devices Develop and maintain QC procedures, inspection methods, and sampling plans Review and approve Device History Records (DHRs) and QC documentation Ensure timely product disposition to support manufacturing and shipping schedules Monitor quality metrics and drive corrective actions where needed Regulatory & Quality System Compliance Maintain compliance with

FDA 21 CFR

Part 820, ISO 13485, and applicable regulatory standards Support internal audits, supplier audits, and external regulatory inspections Ensure calibration and maintenance programs for QC equipment are effective and compliant Maintain controlled documentation, work instructions, and forms Nonconformance & CAPA Support Lead investigations related to nonconforming materials and products Partner cross-functionally with Manufacturing, Engineering, and Quality teams to determine root cause and corrective actions Support CAPA activities and effectiveness checks Continuous Improvement Analyze defect trends, scrap, and process variation data Implement process improvements using SPC, MSA, capability studies, and Lean/Six Sigma tools Drive initiatives focused on efficiency, compliance, and product quality enhancement Qualifications Bachelor's degree in Engineering, Science, or related technical discipline 5+ years of Quality Control or Quality Assurance experience within medical device manufacturing 2+ years of leadership or supervisory experience Strong knowledge of

FDA QSR, ISO

13485, GMP, and risk management principles Experience with statistical quality tools including SPC, MSA, and capability analysis Familiarity with electronic QMS, ERP, and DHR systems Excellent communication, leadership, and problem-solving skills ASQ certifications (CQE, CQM/OE) preferred Additional Information Fully onsite position Competitive benefits package including medical, dental, vision, PTO, and holidays Opportunity to join a collaborative and mission-driven medical device organization focused on improving patient outcomes