Stryker Senior Director, Global Quality Assurance in Portage, Michigan
Stryker is one of the world’s leading medical technology companies and, together with our 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 and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Develops, leads, and executes a Quality Strategy, ensuring that the Quality Strategy is appropriate and effective in meeting the business needs.
Leads pre-market quality assurance, post-market quality assurance, analytical labs, clinical sciences and product safety functions.
Leads Sr. Manager/Directors who lead teams of managers and individual contributors.
Assures that the requirements of 21 CFR Part 820, ISO13485, ISO 14971 and any other applicable government or international standards are implemented and maintained (including those for MDSAP compliance).
Defines, specifies, and/or approves of the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy and reliability of products.
Oversees departmental participation in the reviewing of engineering designs to assure consideration for and compliance to Quality Assurance requirements and considerations.
Responsible for individuals who participate in failure analysis associated with the complaint management system, including documentation of failures, cause of failures, and identification of both immediate and systemic corrective actions and long-term systemic preventative actions.
Responsible for Global CAPA Process executive oversight.
Responsible for ongoing Advanced Quality Engineering executive oversight.
Will conduct internal Quality Assurance compliance audits and communicate results.
Will interface with external auditing entities and communicate results.
Personal contact with customers.
Coaches and develops direct report subordinates.
Responsible for inter-departmental compliance with company policies and corrective actions.
In the event of the absence of the Quality Assurance and Regulatory Affairs Leader, the Department Head of Regulatory Affairs or Quality Assurance will be designated as his/her substitute
Education / Experience:
Bachelors degree in engineering or other relevant field of study required
Master's Degree or equivalent preferred
Six Sigma experience, CQE/CQM/PE certification preferred
10+ years relevant experience required
Previous leadership experience required
Prior experience as an RAQA or technical functional leader required
Preferred experience in a manufacturing and product development environment.
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