Manager, Quality Manufacturing - Stryker Group : Job Details

Stryker is hiring aManager, Quality Manufacturing inSan 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.