Engineer, Service Quality

Stryker•ONIZUKA Air Force Base, CA

33d

About The Position

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.

Requirements

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

Nice To Haves

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

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.