25 feb Senior Manager Post Market Quality & Regulatory
Senior Manager Post Market
Quality & Regulatory
Stryker is one of the world’s leading medical technology companies and together with our customers, we are driven to make healthcare better. The Company offers a diverse array of innovative medical technologies, including reconstructive, medical and surgical, and neurotechnology and spine products to help people lead more active and more satisfying lives.
Stryker products and services are available in over 100 countries. All 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.
The Senior Manager Post Market Quality and Regulatory leads hub and spoke teams to establish, implement, and maintain Global Post Market Quality and Regulatory processes and documents supporting our Product Field Action, Complaint, and Adverse Event processes across Stryker Europe.
- Serve as the voice of the Global Product Field Action and Complaint and Adverse Event processes
- for Stryker Europe.
- Responsible for governance and setting strategic direction of global product field action and complaint
- and adverse event processes.
- Develop, implement and continuously improve Corporate and/or Companywide Quality System
- processes, procedures, and/or electronic systems.
- Act as subject matter expert and mentor for Product Field Action, Complaint, and Adverse Event
- processes throughout Stryker Europe.
- Responsible for partnering and consulting with other Division and Global Quality and Operations
- subject matter experts in product field actions, complaints, and adverse events.
- Communicate effectively to leadership and internal stakeholders, ensuring global initiatives are
- communicated and understood by stakeholders.
- Own global documents and training materials for Global Product Field Action and Complaint and
- Adverse Event processes.
- Assist in developing tools to provide metrics and trends to improve timeliness and efficiency of the processes.
- Degree in Engineering or other relevant field of study.
- Minimum of 8 years of experience in quality assurance/regulatory affairs in a product development and/or manufacturing environment preferred.
- Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and
- Experience in developing, implementing, and/or improving Quality System processes, procedures,
and/or electronics systems required. Experience implementing Companywide initiatives preferred.
- Ability to work independently and enjoy being part of a multi-faceted and virtual team.
- Demonstrated ability to interact effectively with management from other internal and external
- Strong relationship, communication, presentation, problem solving, continuous improvement, data management, and training skills required.
- Preference for knowledge of Lean/Six Sigma methodologies.