Manager, Quality Manufacturing
Manager, Quality Manufacturing
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 youll 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:
Bachelors 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.
Required Experience:
Manager
Employment Type
Full-Time
