Associate Manager, Quality Engineering

Work Flexibility:

Hybrid or Onsite Stryker is hiring an Associate Manger, Quality Engineering in San Jose, CA supporting our Endoscopy division, who will manage and coordinates Quality engineering responsibilities for a team of quality engineers and/or technicians.

What you will do:

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.

What you need:

Required Bachelor's degree in an Engineering related discipline Minimum of 6 years of engineering experience in a regulated environment, with 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. Preferred 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 $133,400 - $222,300 USD Annual View the U.S. work location and transparency guide to find the pay range for your location.

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: www.stryker.com 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.