Manager, Quality Manufacturing

Stryker • San Jose, CA • 18h ago

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.

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.

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.

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