Engineer, Service Quality

Work Flexibility: Onsite

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. You'll drive cost improvements, reduce regulatory risk, and support lean manufacturing initiatives to keep our Service Depot running efficiently.

Key responsibilities include troubleshooting and advising service teams, investigating product issues, documenting defects, analyzing trends, and leading process improvements across multiple product lines.

What You Will Do

• 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.

What You Will Need

Required Qualifications

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

Preferred Qualifications

• 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

$90,400 - $144,200 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer - M/F/Veteran/Disability.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.