Description
Our client, a growing medical device contract manufacturer, is seeking an experienced Quality Control Manager/Supervisor to lead all Quality Control operations in a regulated Class II medical device manufacturing environment.
This is a hands-on leadership role responsible for ensuring that incoming materials, in-process inspections, final product acceptance, and product release activities meet FDA, ISO 13485, customer, and internal quality requirements. You'll work closely with Manufacturing, Engineering, Quality Assurance, Regulatory Affairs, and Supply Chain while leading a team of Quality Control professionals.
Responsibilities:
Lead daily Quality Control operations, including incoming, in-process, and final inspections.
Oversee product release activities and Device History Record (DHR) reviews.
Manage the calibration program for inspection, measuring, and test equipment.
Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and Good Documentation Practices.
Review and disposition incoming inspection results and nonconforming materials.
Participate in CAPA investigations, internal audits, customer audits, supplier audits, and regulatory inspections.
Lead, mentor, and develop Quality Control Inspectors and Technicians.
Analyze quality metrics and implement continuous improvement initiatives.
Partner with cross-functional teams to support manufacturing, validation, and new product introduction activities.
Qualifications:
Required
Bachelor's degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical field (or equivalent experience).
5+ years of Quality Control, Quality Assurance, or Manufacturing Quality experience within the medical device industry.
2+ years of leadership or supervisory experience.
Experience working in a regulated medical device manufacturing environment.
Hands-on experience with:
Incoming inspection
Final product inspection
Product release
Device History Record (DHR) review
Calibration management
Nonconforming material disposition
CAPA participation
Internal and external audits
Preferred
Experience supporting medical device contract manufacturing.
Working knowledge of ISO 14971.
Experience with IQ/OQ/PQ validation activities.
Familiarity with electronic QMS, ERP systems, and calibration software.
ASQ CQE, CQA, CQT, or ISO 13485 Lead Auditor certification.
Knowledge & Skills
Strong understanding of FDA 21 CFR Part 820 and ISO 13485.
Experience with metrology, calibration systems, and statistical inspection methods.
Ability to interpret engineering drawings and technical specifications.
Excellent leadership, communication, organization, and problem-solving skills.
Ability to collaborate across multiple departments in a fast-paced manufacturing environment.
Why Join?
Opportunity to lead Quality Control within a growing medical device manufacturer.
Highly visible role with cross-functional leadership responsibilities.
Influence quality strategy, compliance, and operational excellence.
Work on innovative Class II medical devices in a collaborative, team-oriented environment.