Senior Staff Quality Engineer

Stryker • San Jose, CA

20h • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

Responsibilities

• Work closely with customers, sales/marketing/field personnel, and cross-functional teams to address top quality issues.
• Mentor, provide oversight and approval of NC/CAPA, activist and high-level expert in problem-solving and root-causing activities.
• Lead quality initiatives or projects.
• Provide input into local, global, and corporate processes, represent function on review boards and teams.
• Review and approval of change management activities, challenge effectiveness and drive 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.

Benefits

• Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.
• Stryker is an EO employer – M/F/Veteran/Disability.
• Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior