Job Details

Quality Manager

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

• Bachelors degree in Engineering or related field preferred

Experience

• 710+ 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)
• Six Sigma certification (Green Belt or higher)

Technical Skills

• Strong statistical analysis capabilities (Minitab preferred)
• 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