Senior Manager, Quality - NPI

StrykerSalt Lake City, UT
14hRemote

About The Position

Stryker is seeking a Senior Manager, Quality – NPI to lead a high-performing team at the forefront of innovation in medical device manufacturing. While this role offers remote flexibility, we strongly prefer candidates located near one of our key office hubs: Salt Lake City, UT or Irvine, CA. As Senior Manager, Quality – NPI, you’ll lead a high-performing team driving product transfers that meet the highest standards of quality, safety, and compliance. In this hands-on leadership role, you’ll play a pivotal part in our NPI Quality team—mentoring engineers, guiding cross-functional collaboration, and ensuring every product transfer meets the highest standards of quality, safety, and regulatory compliance. Your work will directly shape the future of life-changing medical technologies

Requirements

  • Bachelor’s degree in Engineering or Science discipline (or equivalent).
  • Minimum 10 years of experience in a regulated manufacturing environment (medical device, pharmaceutical, biomedical, or automotive).
  • Minimum 6 years of experience leading and developing high-performing teams
  • Expert knowledge of regulatory requirements and standards, including FDA inspections/audits
  • Proficiency in quality tools such as SPC, FMEA, Root Cause Analysis, and Six Sigma methodologies
  • Up to 30% domestic and international travel

Nice To Haves

  • MBA or advanced degree in Business Management
  • Experience across multiple sites or roles within quality organizations
  • Familiarity with metrology and interpretation of complex engineering drawings

Responsibilities

  • Drive execution of NPI strategy to develop scalable, high-yield processes that meet launch timelines and quality targets.
  • Optimize inspection strategies through technology, automation, and supplier certification to reduce inspection cost per unit.
  • Coach and develop a team of quality engineers to ensure product transfers meet or exceed established performance metrics.
  • Ensure compliance by implementing robust production and process controls throughout the manufacturing lifecycle.
  • Collaborate globally with QA leaders to harmonize best practices and share lessons learned across regions.
  • Lead supplier onboarding by validating process capability and implementing pFMEA, PPAP, and certification requirements.
  • Drive continuous improvement in metrology, process validation, and inspection methods to enhance efficiency and accuracy.
  • Monitor and improve product quality indicators such as supplier DPM, right-first-time rates, and manufacturing complaints per million units.

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What This Job Offers

Job Type

Full-time

Career Level

Senior

Number of Employees

5,001-10,000 employees

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