Senior Quality Engineering Leader – Medical Devices

Stryker; San Jose (CA); Vor Ort; USD 133.000 - 222.000; Vollzeit

Benefits dieser Stelle

Health insurance

Dental insurance

Vision insurance

Critical illness insurance

Accident insurance

Hospital indemnity insurance

Wellbeing program

Tobacco cessation program

HSA

FSAs

401(k)

ESP P

Life and AD&D insurance

Short-term disability

Zusammenfassung

Stryker is hiring a Senior Staff Quality Engineer for the Endoscopy division in San Jose, CA to provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement.

You will mentor teams, lead quality initiatives, manage audits and CAPA, and ensure compliance with medical device regulations. This role requires collaboration across functions and a passion for data-driven quality improvements.

Qualifikationen

• Minimum 6 years of experience in Quality and/or R&D in the medical device industry.
• Strong knowledge of ISO 13485, GDP, GMP, post-market requirements, and global regulations.
• Experience leading root cause investigations, CAPA, complaint investigations, and post-market quality initiatives.

Aufgaben

• Collaborate with customers, sales, field personnel and cross-functional teams to address top quality issues.
• Mentor and provide oversight of NC/CAPA and high-level problem solving.
• Lead quality initiatives or projects and act as process owner across multiple quality areas.
• Provide input into local and global processes and participate in review boards and teams.
• Review and approve change management activities and drive effectiveness of reviews.
• Interpret KPI trends and drive continuous improvement.
• Engage in audits with regulatory reps and manage audit logistics if needed.
• Support ship/holds and potential product escapes; coach others in quality topics.

Kenntnisse

Quality leadership

Root cause analysis

CAPA management

Regulatory compliance

Ausbildung

Bachelor’s degree in science/engineering

Master’s degree (preferred)

Jobbeschreibung

Stryker is hiring a Senior Staff Quality Engineer for the Endoscopy division in San Jose, CA to provide quality engineering leadership and technical guidance in quality assurance, control, and preventative activities with a focus on continuous improvement.

You will mentor teams, lead quality initiatives, manage audits and CAPA, and ensure compliance with medical device regulations. This role requires collaboration across functions and a passion for data-driven quality improvements.