Associate Manager, Quality Engineering

Stryker • San Jose, CA

4d • Hybrid

About The Position

Stryker is hiring an Associate Manager, Quality Engineering in San Jose, CA supporting our Endoscopy division, who will manage and coordinate Quality engineering responsibilities for a team of quality engineers and/or technicians. This role involves providing full people management responsibility for salaried and/or hourly Quality team members, including performance management, talent reviews, development planning, and employee engagement. The Associate Manager will build and maintain a high-performing, engaged team through regular 1:1s, clear performance objectives, and alignment to business strategy and quality goals. They will own the Quality staffing strategy, including hiring, talent development, workload prioritization, and coordination of direct report activities. The role also drives continuous improvement by establishing KPIs, monitoring metrics, and implementing process improvement methodologies across the Quality organization. Additionally, the Associate Manager will partner cross-functionally with Project Managers, Engineering, and other functional leaders to ensure appropriate resourcing and quality support for programs and projects. They will support new product development and lifecycle management activities, including design support, change control review, and ensuring launches meet quality, regulatory, and user requirements. The position oversees Quality System execution, including complaint handling, MDR/MDV reporting, CAPA/NC review, product ship holds, and product field action decisions. Finally, the Associate Manager will serve as a subject matter expert in applicable domestic and international regulations and standards (e.g., FDA QSR, ISO 13485), including participation in FDA and Notified Body inspections.

Requirements

• Bachelor’s degree in an Engineering related discipline
• Minimum of 6 years of engineering experience in a regulated environment
• Working knowledge of one or more of the following standards: ISO 9001, ISO 13485, FDA 21 CFR Part 820, and/or ISO 14971 risk management.

Nice To Haves

• Master’s degree in an Engineering related discipline
• 1+ years of demonstrated experience leading high‑performing teams with strong leadership and effective interpersonal communication skills

Responsibilities

• Provide full people management responsibility for salaried and/or hourly Quality team members, including performance management, talent reviews, development planning, and employee engagement.
• Build and maintain a high-performing, engaged team through regular 1:1s, clear performance objectives, and alignment to business strategy and quality goals.
• Own Quality staffing strategy, including hiring, talent development, workload prioritization, and coordination of direct report activities.
• Drive continuous improvement by establishing KPIs, monitoring metrics, and implementing process improvement methodologies across the Quality organization.
• Partner cross-functionally with Project Managers, Engineering, and other functional leaders to ensure appropriate resourcing and quality support for programs and projects.
• Support new product development and lifecycle management activities, including design support, change control review, and ensuring launches meet quality, regulatory, and user requirements.
• Oversee Quality System execution, including complaint handling, MDR/MDV reporting, CAPA/NC review, product ship holds, and product field action decisions.
• Serve as a subject matter expert in applicable domestic and international regulations and standards (e.g., FDA QSR, ISO 13485), including participation in FDA and Notified Body inspections.

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.
• 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!

What This Job Offers

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