Medical Device Document Specialist
| Category: | Professional |
| Location: | Lehi, UT 84003 |
| Pay: | $30.00 Hourly |
| Posted: | 1 day ago |
| Status: | Open |
Description
Medical Device Document Specialist
Quality System Specialist is responsible for supporting, maintaining, and improving the Quality Management System (QMS) to ensure compliance with ISO 13485, FDA 21 CFR Part 820, MDR (Medical Device Regulation), and other applicable regulations
What's in it for you?
Elwood Professional associates are eligible for a comprehensive and competitive benefits package plus an exclusive savings program, including:
- Medical/Vision/Dental/Rx plans
- Holiday Pay
- Teladoc (online care)
- Referral Bonus Incentive
- And More!
Medical Device Document Specialist Details:
Contract position- $
30.00 / hour First Shift
- Maintain and improve the Quality Management System (QMS) to comply with medical device regulations and industry standards.
- Manage document control processes, ensuring proper approval, revision, and distribution of quality-related documents.
- Collaboration in document creation with Department Owners.
- Coordinate and conduct internal audits to ensure compliance with regulatory and company requirements. Assist in external audits and inspections from regulatory bodies (e.g., FDA, ISO auditors, notified bodies).
- Support CAPA (Corrective and Preventive Action) investigations, root cause analysis, and effectiveness verification. Monitor and track non-conformance reports (NCRs) and ensure timely resolution.
- Support supplier quality management, including supplier audits and performance monitoring.
- Maintain training records and ensure personnel are trained on quality policies and procedures.
- Assist in risk management activities, ensuring proper documentation and compliance with ISO 14971.
- Support change control processes, ensuring proper evaluation and implementation of changes affecting product quality.
- Prepare and maintain quality system metrics and reports for management review.
Medical Device Document Specialist Qualifications:
- Familiarity with managing approval workflows within a Part 11 compliant eQMS software
- Familiarity with CAPA, audits, document control, QMS processes. 2-5 years of experience in a regulated industry such as medical device, pharma or biotech.
- Strong analytical and communication skills.
- Ability to work in a fast pace / cross functional environment and support QMS continuous improvement activities.
- Applicant may be subject to a background check
We are an Equal Opportunity Employer and celebrate diversity at all levels of our organization.
Our commitment to you: to be Kind, Helpful, Respectful, Honest and Committed To Finding You Work.
How to Apply:
Email, call, or text us today! Feel free to apply online at www.elwoodjobs.com!
Spencer Barker
3025 Washington Blvd
Ogden, UT 84401
(801) 781-2305 ext.
spencer.barker@elwoodprofessional.com
Qualifications
*See above for qualifications
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