Stryker is hiring a Manager, Quality Manufacturing in San Jose, CA! As a leader for the Service business, you will lead a team of engineers responsible for developing and sustaining Service manufacturing processes that meet quality standards. You will oversee the establishment and maintenance of quality standards for repaired products and associated processes. Additionally, you will drive cost improvements, minimize regulatory compliance risks, and support the implementation of lean manufacturing principles to enhance overall service business performance.
This team is essential in enabling the Service Depot to effectively diagnose, repair, or refurbish medical devices and or their components.
What you’ll do:
Ensure compliance with applicable global regulations and standards (e.g., QSR, ISO, EN, FDA, and Medical Device Directive) by collaborating across functions to define quality standards and clarify roles and responsibilities.
Develop the team through continuous coaching and formal performance appraisals.
Foster a positive team environment with open communication and engaged team members.
Lead cross-functional projects with manufacturing and supply chain teams, leveraging lean principles to reduce waste in the repair value stream.
Address field failures by implementing product and service process improvements to enhance product quality.
Set and maintain up-to-date standards for product quality.
Lead service audits (internal and external, including Corporate and ISO/FDA) and monitor key quality metrics to drive continuous improvements.
Ensure the team thoroughly investigates and processes nonconformances.
Facilitate smooth product transfers of new products from the Service NPD engineers.
Field questions from the field around quality of repair or repair concerns
What you need:
Required:
Bachelor’s degree in engineering, science or related discipline required.
8+ years of experience in engineering, quality, regulated manufacturing, or a similar environment required.
2+ years’ experience of people management.
Preferred:
Strong interpersonal skills and ability to work through ambiguity and changes
Strong understanding of Lean Six Sigma methodologies and continuous improvement frameworks
Knowledge of applicable domestic and international regulations and quality system standards – FDA QSR, MDD, ISO3485, ISO9001, etc.
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.