Position Overview A leading manufacturer within the medical device and pharmaceutical packaging space is seeking a Quality Manager to lead site-level quality operations. This individual will be responsible for managing the Quality Management System (QMS), ensuring compliance with regulatory standards, and driving continuous improvement across manufacturing processes.
This is a hands-on leadership role overseeing quality personnel while partnering closely with operations and engineering to support production, validation, and new product launches.
Key Responsibilities
Lead and develop Quality Engineers, QA staff, and Inspectors while ensuring coverage across all shifts
Own and maintain the Quality Management System in compliance with ISO 13485 and FDA 21 CFR 820
Serve as site quality leader and Management Representative, reporting QMS performance to leadership
Lead internal, external, and customer audits, including FDA and surveillance audits
Develop and manage internal audit programs, including execution, reporting, and corrective actions
Oversee validation activities, including IQ, OQ, PQ, and process capability studies
Support new product development, tooling changes, and specification updates through protocol development and data analysis
Drive root cause analysis, CAPA activities, and scrap reduction initiatives
Analyze quality and production data (SPC, DOE, GR&R, process capability) to identify trends and improvements
Act as primary quality contact for customer complaints, audits, and quality-related communication
Ensure customer requirements, prints, and specifications are translated into production standards
Establish and improve inspection methods, control plans, and AQL standards
Ensure execution of first article inspections, measurement systems, and documentation control
Lead training initiatives for quality and production personnel on inspection and quality standards
Maintain calibration systems and ensure inspection equipment is compliant and accurate
Partner cross-functionally with operations and engineering to improve manufacturability and reduce the cost of poor quality
Qualifications
Education
Bachelor’s degree in Engineering or related field preferred
Experience
7–10+ years of quality experience within a manufacturing environment
Prior leadership experience managing quality teams
Strong experience in regulated environments (ISO 13485 and/or FDA)
Hands-on experience with validations (IQ/OQ/PQ) and statistical analysis
Certifications (Preferred)
ASQ Certified Quality Manager (CMQ/OE) or Certified Quality Engineer (CQE)
Experience with DOE, GR&R, SPC, process capability, and FMEA
Ability to read and interpret engineering drawings and technical specifications
Benefits
401(k) with company match
Annual bonus
Medical, dental, and vision insurance
Paid time off
If you are interested in this position, please apply here or send your resume to matthew@mrrecruiter.com.
Equal Opportunity Employer Disclaimer
This organization is an Equal Opportunity Employer and is committed to creating an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability status, genetic information, protected veteran status, or any other characteristic protected by applicable law. Employment decisions are based solely on qualifications, merit, and business needs.