Manager, Quality Assurance – New Product Introduction
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Salt Lake City • Utah • United States
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About the role
- Lead the execution of NPI quality strategy to develop capable, scalable manufacturing processes and high‑yield product launches.
- Drive robust pFMEA, CQA identification, process validation, process capability, and supplier capability to ensure accurate risk identification and strong process controls.
- Oversee implementation of production and process controls, inspection strategies, and test method validations to support high-quality, low‑cost product introductions.
- Partner cross‑functionally with Design, Advanced Operations, GQO, and suppliers to strengthen collaboration, share best practices, and harmonize global NPI QA processes.
- Coach, develop, and empower NPI QA team members, ensuring strong technical capability, metrology expertise, and performance management practices.
- Build organizational capability through optimized, lean inspection approaches, automation opportunities, supplier certification, and technology‑enabled improvements.
- Monitor and influence quality performance indicators (supplier DPM, RFT, manufacturing loss, complaints, recalls) and identify opportunities for continuous improvement.
- Ensure adherence to corporate, GQO, and external regulatory requirements (including FDA and global standards), supporting high-quality design transfers and compliant product launches.
Requirements
- Bachelor’s Degree in Engineering, Science discipline or equivalent
- Minimum of 8 years’ experience in medical device, pharmaceutical, biomedical, aerospace, automotive or other regulated manufacturing environments
- Minimum of 2 years’ experience and a proven track record of successfully building, managing, and developing a highly talented, engaged and performing team
- Expert working knowledge of regulatory requirements, standards, and regulations, with experience of managing inspections/audits by the FDA and other regulatory bodies
- Proven ability to build trust, navigate cross‑functional relationships, and advocate for quality in a technical environment
- Preferred MBA or background in Business Management
- Proficiency in quality tools such as SPC, FMEA, RCA, Poka‑Yoke, and Six Sigma methodologies
- Experience across multiple quality roles, sites, or functions
- Expertise in metrology, GD&T, and interpretation of complex engineering drawings
Benefits
- Work Flexibility: Hybrid or Onsite
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
NPI quality strategypFMEACQA identificationprocess validationprocess capabilitysupplier capabilitymetrologyGD&TSix Sigmaquality tools
Soft Skills
coachingteam developmentcross-functional collaborationtrust buildingadvocacy for qualityperformance managementempowermentcommunicationleadershipcontinuous improvement
Certifications
Bachelor’s Degree in EngineeringBachelor’s Degree in ScienceMBAquality certifications