Engineer, Service Quality jobs in United States
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Stryker · 2 days ago

Engineer, Service Quality

Stryker is hiring an Engineer, Service Quality in San Jose, CA! In this role, you’ll support service processes, ensuring quality standards for repaired, refurbished, and returned medical devices while driving cost improvements and supporting lean manufacturing initiatives.

BiotechnologyHealth CareLife ScienceMedicalMedical Device
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Growth Opportunities
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H1B Sponsor Likelynote

Responsibilities

Maintain compliance and quality standards for repair and refurbishment processes
Lead implementation of process improvements to enhance efficiency and reduce regulatory risk
Drive continuous improvement initiatives to reduce lead time, cost, and quality issues
Monitor and analyze key quality metrics, taking proactive corrective actions
Own and manage nonconformances (NCs) and corrective/preventive actions (CAPAs) for assigned products
Troubleshoot moderately complex product quality issues using data-driven analysis
Ensure accurate documentation for inspection, testing, and repair procedures, and train technicians on updates
Partner with technicians and supervisors to optimize processes and meet demand requirements
Process supplier requests and maintain supporting documentation
Provide input and support implementation of repair and testing mechanisms and equipment
Validate equipment and third-party repaired components to ensure compliance
Contribute to new product development by recommending efficient repair techniques based on current data
Support internal and external audits, including FDA and Notified Body inspections

Qualification

FDA QSR knowledgeISO13485 knowledgeLean Six SigmaRoot cause analysisManaging NCsCAPAsEngineering degreeManufacturing experienceQuality experienceInternship experience

Required

Bachelor's degree in engineering, science, or related
0+ years of experience in engineering, manufacturing, quality, or a highly regulated industry

Preferred

Internship experience in quality, engineering, or manufacturing is strongly preferred
Knowledge of FDA QSR, ISO13485, ISO9001, and related quality system standards
Experience managing NCs and CAPAs
Lean, Six Sigma, and root cause analysis methodologies

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
Chair & CEO
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Glenn S. Boehnlein
Chief Financial Officer and Vice President
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Company data provided by crunchbase