Stryker
is hiring a Senior Staff Quality Engineer for our 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 of products and processes. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance with regulation and standards.
What you will do
- Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
- Mentors, provides oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
- Leads quality initiatives or projects.
- Recognized process owner, with expertise across multiple quality areas.
- Provides input into local, global, and corporate processes, represents function on review boards and teams.
- Review and approval of change management activities, challenges effectiveness and drives strong review.
- Interpret KPI trends, drive continuous improvement process.
- Advocate of Human Factor practices, proficiency in the science of identification of mitigation.
- Engage in and may lead internal and external audits with regulatory representatives, providing effective narrative and description of topic of expertise and overview of the business. May manage audit logistics and/or preparation.
- Responsible for initiation, internal containment, and support of ship and product holds for potential product escapes.
- Coach and mentor others in quality topics and activities.
Required
- Bachelor’s degree in a science, engineering or related discipline.
- Minimum 6 years of experience in Quality and/or Research & Development (R&D) within the medical device industry, supporting product development, design controls, risk management, quality systems, and post-market surveillance activities.
- Strong knowledge of medical device quality and regulatory requirements, including ISO 13485, Good Documentation Practices (GDP), Good Manufacturing Practices (GMP), post-market compliance requirements, and U.S. and international medical device regulations.
- Experience leading and supporting root cause investigations, nonconformance management, CAPA activities, complaint investigations, and post-market quality initiatives to drive continuous improvement and regulatory compliance.
Preferred
- Masters degree
- Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.)
- Strong knowledge of Quality Concepts (e.g. Risk Management, CAPA, Audits, Statistics).
- ASQ Certified Quality Engineer (CQE) and/or Certified Reliability Engineer (CRE) certification preferred.
- Six Sigma Green Belt or Black Belt certification preferred, with demonstrated application of continuous improvement and process optimization methodologies.
