About this role
Work Flexibility: Onsite
As a Quality Management Systems Specialist, you will support the administration and continuous improvement of document and change control processes within a regulated medical device environment. You will coordinate controlled documentation, quality records, and change activities while partnering with cross-functional teams to maintain compliance with Quality Management System requirements.
What you will do
• 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 Quality Management System 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 support 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 established retention, integrity, accessibility, and record-management requirements.
• Collaborate with cross-functional partners to create and revise procedures, resolve documentation discrepancies, and communicate technical information accurately.
• Guide Document Control team members and monitor metrics to identify opportunities for continuous improvement.
What you will need
Required
• 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 proficiency , including the ability to read, understand, and communicate technical information.
• Professional experience using Microsoft Office 365 .
Preferred
• Bachelor’s degree in Science, Engineering, Biochemistry, Biotechnology, Biology, Biomedical Engineering , or a related field.
• Experience supporting document control, change control, or Quality Management Systems within the medical device or another regulated industry .
Travel Percentage: 10%