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Quality Assurance ManagerMRINetwork • Phoenix, AZ, United States
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Quality Assurance Manager

Quality Assurance Manager

MRINetwork • Phoenix, AZ, United States
30+ days ago
Job type
  • Full-time
Job description

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
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Quality Assurance Manager • Phoenix, AZ, United States

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