Quality Assurance Manager

Title: Quality ManagerLocation: Phoenix, AZPosition OverviewA 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 ResponsibilitiesLead and develop Quality Engineers, QA staff, and Inspectors while ensuring coverage across all shiftsOwn and maintain the Quality Management System in compliance with ISO 13485 and FDA 21 CFR 820Serve as site quality leader and Management Representative, reporting QMS performance to leadershipLead internal, external, and customer audits, including FDA and surveillance auditsDevelop and manage internal audit programs, including execution, reporting, and corrective actionsOversee validation activities, including IQ, OQ, PQ, and process capability studiesSupport new product development, tooling changes, and specification updates through protocol development and data analysisDrive root cause analysis, CAPA activities, and scrap reduction initiativesAnalyze quality and production data (SPC, DOE, GR&R, process capability) to identify trends and improvementsAct as primary quality contact for customer complaints, audits, and quality-related communicationEnsure customer requirements, prints, and specifications are translated into production standardsEstablish and improve inspection methods, control plans, and AQL standardsEnsure execution of first article inspections, measurement systems, and documentation controlLead training initiatives for quality and production personnel on inspection and quality standardsMaintain calibration systems and ensure inspection equipment is compliant and accuratePartner cross-functionally with operations and engineering to improve manufacturability and reduce the cost of poor qualityQualificationsEducationBachelor's degree in Engineering or related field preferredExperience7-10+ years of quality experience within a manufacturing environmentPrior leadership experience managing quality teamsStrong experience in regulated environments (ISO 13485 and/or FDA)Hands-on experience with validations (IQ/OQ/PQ) and statistical analysisCertifications (Preferred)ASQ Certified Quality Manager (CMQ/OE) or Certified Quality Engineer (CQE)Six Sigma certification (Green Belt or higher)Technical SkillsStrong statistical analysis capabilities (Minitab preferred)Experience with DOE, GR&R, SPC, process capability, and FMEAAbility to read and interpret engineering drawings and technical specificationsBenefits401(k) with company matchAnnual bonusMedical, dental, and vision insurancePaid time offIf you are interested in this position, please apply here or send your resume to matthew@mrrecruiter.com.Equal Opportunity Employer Disclaimer