Senior Manager, Quality - NPI jobs in United States
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Stryker · 5 hours ago

Senior Manager, Quality - NPI

Stryker is seeking a Senior Manager, Quality – NPI to lead a high-performing team at the forefront of innovation in medical device manufacturing. This role involves driving product transfers that meet the highest standards of quality, safety, and compliance, while mentoring engineers and collaborating across functions.

BiotechnologyHealth CareLife ScienceMedicalMedical Device
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Growth Opportunities
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H1B Sponsor Likelynote

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

Qualification

Regulatory requirements knowledgeQuality tools proficiencyTeam leadership experienceEngineering degreeExperience in regulated manufacturingMBAAdvanced degreeMetrology familiarity

Required

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

Preferred

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

Benefits

Bonus eligible
Benefits

Company

Stryker is a medical technology company that offers products and services in orthopaedics.

H1B Sponsorship

Stryker has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (105)
2024 (76)
2023 (63)
2022 (78)
2021 (57)
2020 (77)

Funding

Current Stage
Public Company
Total Funding
unknown
1990-01-02IPO

Leadership Team

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Kevin Lobo
Chief Executive Officer
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Glenn S. Boehnlein
Chief Financial Officer and Vice President
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Company data provided by crunchbase