Staff Quality Management Systems Specialist (Onsite)

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%