Quality Assurance Manager

Title: Quality Manager

Location: Phoenix, AZ

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)
• 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

If you are interested in this position, please apply here or send your resume to [email protected].

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.