Stryker · 1 day 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
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
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
Medical and prescription drug insurance
Dental insurance
Vision insurance
Critical illness insurance
Accident insurance
Hospital indemnity insurance
Personalized healthcare support
Wellbeing program
Tobacco cessation program
Health Savings Account (HSA)
Flexible Spending Accounts (FSAs)
401(k) plan
Employee Stock Purchase Plan (ESPP)
Basic life and AD&D insurance
Short-term disability insurance
Company
Stryker
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 CompanyTotal Funding
unknown1990-01-02IPO
Recent News
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2025-02-11
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