Engineer, Service Quality

Stryker•San Jose, CA

1d•Onsite

About The Position

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.

Requirements

Bachelor’s degree in engineering, science, or related.
0+ years of experience

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.