Associate Manager, Quality Engineering

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.

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.