Document Control Specialist
About The Position
The Document Control Specialist maintains the Document Control system for the Quality Management System, including document creation, issuance, storage, access, and distribution. The role follows good documentation practices (GDP), ISO 13485, and FDA requirements. This is an on-site position at Tegra Medical’s Franklin, Massachusetts facility, with a Monday–Friday schedule from 7:00 AM to 3:30 PM. The specialist supports document and traveler change requests, maintains document revisions and records, and facilitates Device History Record (DHR) control, including storage and retrieval from an off-site facility. The role also supports quality documentation, employee training records, production shipment certification, customer return authorizations, and related quality-system processes.
Requirements
- High school diploma or equivalent.
- Two years of related experience is desirable.
- Ability to edit and format documents using Microsoft Office applications such as Word, Excel, and/or PowerPoint.
- Experience in a document control function in a manufacturing environment; medical device industry experience is preferred.
- Knowledge and experience with a certified quality system, ISO 13485:2016, and/or FDA QSR 21 CFR 820.
- Ability to write simple correspondence and effectively present information in one-on-one and small-group situations to customers, clients, and other employees.
- Regular attendance in the office is required.
Nice To Haves
- Experience in the medical device industry.
- Two years of related experience.
Responsibilities
- Support document changes and applicable databases.
- Ensure quality documents and records are complete, properly stored and revised, maintain their integrity, and have appropriate approvals.
- Manage document and traveler change requests, reviewing relevant information before closure.
- Review, file, and manage storage of DHR files, including final review and verification of signoffs and GDP.
- Review Order Launch entries to verify that inspection documents match customer and internal specifications.
- Prepare documentation for filing at an off-site storage facility.
- Issue customer return authorizations and create return pack lists for issuing credit.
- Prepare procedures and work instructions in the appropriate format; review documents for grammar and syntax before approval.
- Maintain Quality document revision levels.
- Support and facilitate DHR documentation control, including sending records to and retrieving them from off-site storage.
- Maintain the integrity of Customer DHRs by verifying essential-record completeness, good documentation practices, and proper signoffs.
- Perform the job certification process on production job shipments at the Franklin facility.
- Set up newly hired employees in QMS databases.
- Assist with Change Control by gathering jobs from production and making changes according to Change Requests.
- Maintain employee training requirements in the Unipoint database.
- Enter completed training and create training sign-off reports for new and transferred employees and document updates; send applicable reports to supervisors.
- Perform other duties as assigned.
Benefits
- On-the-job training and advancement opportunities.
- Competitive hourly wage and shift differentials for second and third shifts.
- Health, dental, vision, life, and disability insurance.
- 401(k).
- Paid time off, sick time, and holiday pay.
- Employee Assistance Program.
- Tuition reimbursement.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
