Senior Staff Quality Engineer

Work Flexibility: Hybrid 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. $133,400 - $222,300 USD Annual Travel Percentage: 10% 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. Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. We are proud to be named one of the World’s Best Workplaces! For more information, visit: Work Flexibility Remote – Role allows you to work the majority to 100% of time from an alternate workplace. These roles could have travel expectations, and you must work within the country of the job requisition location. Field-based – You can expect to regularly work a majority to 100% of time at customer facilities and has a set territory or expectation to travel within a set boundary. Almost all sales roles would likely be qualified as field-based. Onsite – Role is 100% located at a Stryker facility. Some ad hoc flexibility may be available depending on role, level, and job requirements. Manufacturing roles and any role that requires physical presence at the office would qualify under this category. Hybrid – You can expect to regularly work in both an alternate workplace and a Stryker facility. Roles that are partially remote or co-located would qualify as hybrid, and the expectation to be onsite would be defined and agreed upon by your manager/supervisor.