Staff Specialist, Quality Management Systems
Staff Specialist, Quality Management Systems
Portage, MI
Stryker is seeking a Staff Specialist, Quality Management Systems to lead the development and maintenance of our Quality Management System (QMS) in compliance with global medical device regulations. This role ensures the QMS is effective, efficient, and audit-ready, supporting regulatory clearance and certification efforts.
Work Flexibility:
Hybrid: Candidates must reside within a commutable distance to Portage, MI, and be able to work onsite several times per week.
What you will do:
- Serve as the Instruments Division Process Owner for internal and external audits, managing logistics, tools, and training.
- Maintain and improve QMS documentation related to audit processes and represent the division during audits.
- Act as the liaison between the Global Process Owner and the division to implement QMS initiatives and improvements.
- Manage QMS documentation requests in onePLM, including creating and tracking change requests.
- Prioritize and ensure timely completion of documentation tasks based on internal and external deadlines.
- Lead gap assessments for regulations and standards (e.g., ISO 13485) and drive remediation efforts.
- Oversee implementation of corporate requirements and Managed Release reviews across the Instruments Division.
- Support cross-functional teams as the voice of Quality, contributing to strategy and continuous improvement.
What you need:
Basic Qualifications:
- Bachelor’s degree.
- 4+ years of experience in Quality Systems (e.g., CAPA, audits, Management Review, Quality Planning)
Preferred Qualifications:
- PMP certification or strong project management experience.
- Familiarity with Windchill and TrackWise systems
- Knowledge of U.S. and international medical device regulations
- Ability to lead complex strategy and project execution at several sites and determine/implement processes for introduction of new sites.
- Strong stakeholder engagement and customer service mindset
Average salary estimate
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