Senior Staff Quality Engineer Med Device Process Leader

Stryker; San Jose (CA); On-site; USD 133,000 - 222,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Employee Stock Purchase Plan (ESPP)

Job summary

Stryker is hiring a Senior Staff Quality Engineer in San Jose, CA to provide leadership across quality assurance, control, and preventative activities. The role focuses on continuous improvement of products and processes and mentoring teammates in problem-solving and regulatory compliance.

You will interact with customers and cross-functional teams, review change management, and drive KPI-based improvements while ensuring US and international medical device regulations are met.

Qualifications

• Bachelor’s degree in a science, engineering or related discipline.
• Minimum 6 years of experience in Quality and/or R&D within the medical device industry.
• Strong knowledge of medical device quality and regulatory requirements (ISO 13485, GDP, GMP, post-market requirements, and regs).
• Experience leading root cause investigations, CAPA, nonconformance, and post-market quality initiatives.

Responsibilities

• Work with customers and cross-functional teams to address top quality issues.
• Mentor and provide oversight of NC/CAPA activities and root cause analysis.
• Lead quality initiatives or projects and own processes across multiple areas.
• Contribute to local, global and corporate processes; represent function on reviews.

Skills

Quality leadership

Regulatory compliance

Root cause investigations

Process improvement

Cross-functional collaboration

Education

Bachelor's degree in science/engineering

Master's degree (preferred)

Job description

Stryker is hiring a Senior Staff Quality Engineer in San Jose, CA to provide leadership across quality assurance, control, and preventative activities. The role focuses on continuous improvement of products and processes and mentoring teammates in problem-solving and regulatory compliance.

You will interact with customers and cross-functional teams, review change management, and drive KPI-based improvements while ensuring US and international medical device regulations are met.