Staff Quality Management Systems Specialist (Onsite)

About the role

Stryker is looking for a Staff Quality Management Systems Specialist (onsite) to support the administration and continuous improvement of document and change control processes in a regulated medical device environment. You will coordinate controlled documentation, quality records and change activities while working with cross-functional teams to stay compliant with Quality Management System requirements.

Key responsibilities

• Coordinate document and change control activities, including the release, revision, implementation and maintenance of controlled documents in electronic systems.
• Review quality records for compliance with Good Documentation Practices (GDP), established procedures and QMS requirements.
• Review change orders and supporting documentation to verify compliance with document and change control procedures.
• Track documentation reviews, approvals, implementation activities and closure to ensure timely completion of document changes.
• Verify completion of change-control activities, including material disposition and required training, before closure.
• Maintain controlled documents and records according to retention, integrity, accessibility and record-management requirements.
• Collaborate with cross-functional partners to create and revise procedures, resolve documentation discrepancies and share technical information accurately.
• Guide Document Control team members and monitor metrics to identify opportunities for continuous improvement.

Required profile

• Associate degree from an accredited college or university, or equivalent relevant experience.
• Minimum 5 years of experience in Document Control, Quality Systems, or a combination of both.
• Intermediate to advanced English, including reading, understanding and communicating technical information.
• Preferred: Bachelor's degree in Science, Engineering, Biochemistry, Biotechnology, Biology, Biomedical Engineering or a related field.
• Preferred: experience supporting document control, change control or Quality Management Systems in the medical device or another regulated industry.

Required skills

• Professional experience using Microsoft Office 365.