Position Summary
Primarily responsible for the strategic development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversees and ensures that an effective and efficient quality management system is built and maintained while providing technical leadership. Ensures that all applicable quality system regulations are met to receive regulatory clearance/certification.
Key Responsibilities
1. Ensure QMS compliance with internal and external regulatory requirements, including FDA, ISO, MDD, and country-specific regulations.
2. Maintain an optimum state of QMS for current and future business needs.
3. Identify and implement strategic improvements in the quality planning process.
4. Drive development and modification of Stryker's QMS.
5. Assess and optimize QMS structure to meet business needs.
6. Ensure GMP and GDP compliance within the Quality organization.
7. Develop and maintain policies and procedures to enhance QMS efficiency and effectiveness.
8. Provide training on QMS areas of expertise.
9. Drive best-in-class practices and benchmark against industry leaders and regulatory requirements.
10. Liaise with notified bodies to manage certification changes.
11. Evaluate QMS to reflect actual activities, business needs, and support NPD requirements.
12. Manage QMS activities to achieve project milestones.
13. Lead improvement processes and execute projects.
14. Own QMS business processes and understand IS system support requirements.
15. Represent expertise during internal and external quality system audits.
16. Demonstrate strong knowledge of system integration.
Additional Responsibilities
1. Coordinate input, feedback, and represent divisional needs.
2. Accountable for local process and training implementation.
3. Update the GPO and/or PMO on divisional deliverables and progress.
4. Communicate global initiatives to divisional stakeholders.
5. Serve as the voice for the division in the process area.
6. Attend hub and spoke meetings.
7. Engage in meetings, surveys, information gathering, and decision-making.
8. Deliver against agreed project deadlines.
9. Communicate with leadership and stakeholders at all levels within the division/site.
Requirements
* BS in a science, engineering, business, or related discipline.
* Minimum 7 years of experience in a manufacturing environment or equivalent.
* Regulated environment experience and interaction with regulatory agencies required.
* Prior divisional or site experience desirable.
Knowledge and Competencies
* Thorough knowledge of US and International Medical Device Regulations.
* Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.).
* Excellent communication, project management, and influencing skills.
* Ability to plan, organize, and implement multiple concurrent tasks.
* Strong interpersonal skills, written, oral communication, and negotiation skills.
* Analytical and problem-solving capabilities with data-driven insights.
* Demonstrated ability to work in cross-functional team environments.
* Builds strong relationships through open communication, respect, and trust.
* Achieves desired outcomes with customer service/stakeholder-focused approach.
* Presents as a change agent with a continuous improvement orientation.
* Acts as the voice of Quality in cross-functional teams, ensuring appropriate outcomes.
* Computer literacy.
* Some travel may be required.