Engineer, Service Quality

Stryker is hiring an Engineer, Service Quality in San Jose, CA! In this role, you will support service processes that meet quality standards by developing and maintaining requirements for repaired, refurbished, or returned products. You will also drive cost improvements, reduce regulatory risk, and support lean manufacturing initiatives, helping the Service Depot effectively diagnose, repair, and refurbish medical devices and components.

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

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.