Document Control Specialist

Join Our Team at Tegra Medical! We’re a trusted contract manufacturer for some of the biggest names in the medical device industry. Known for taking on complex projects that others can’t, we pride ourselves on precision and innovation. Headquartered in Franklin, MA, Tegra Medical is part of the global SFS Group, based in Heerbrugg, Switzerland. Together, we’re shaping the future of healthcare.

Job Summary This position is on-site located at our Franklin, MA facility. The Document Control Specialist maintains the Document Control system which involves creation, issuance, storage, access, and distribution of all documents that support the Quality Management System, following all GDP rules and ISO 13485 and FDA requirements.

Role and Responsibilities

• Supports the change of document process and applicable databases.
• Ensure completeness of the storage, revision, integrity of the record and proper approval for all Quality documents and records
• Manage document and traveler change requests including review of all relevant information prior to closure.
• Review, file, and manage storage of all DHR files including final review and verification of proper signoffs and GDP.
• Review Order Launch entries to verify inspection documents match customer as well as internal specifications.
• Prepare documentation for filing in off-site storage facility.
• Issue Return Authorizations for customer returns and create return pack lists for issuing credit.
• Prepare procedures and work instructions in the appropriate format. Review documents for grammar and syntax before sending them for approval.
• Maintain Quality document revision levels.
• Support and facilitate Device History Records (DHR) documentation control including sending and retrieving records to the off-site storage facility.
• Maintain the integrity of the Customer DHR's by ensuring completeness of the essential records, good document practices are followed and verifying the proper document signoffs.
• Perform job certification process on production job shipments/Franklin.
• Set up newly hired employees in QMS databases.
• Assist with the Change Control process, gathering jobs from the production area and making changes per the Change Request.
• Maintain Employee Training requirements in Unipoint database.
• Enter completed training. Create Training sign-off reports for new and transferred employees and send them to the applicable Supervisor. Create training sign-off reports for document updates.
• Other duties as assigned.

Qualifications

• 2 years of related experience is desirable.
• Must be able to edit and format documents using Microsoft Office applications, i.e., Word, Excel and/or PowerPoint
• Experience working in a document control function in a manufacturing environment, preferably medical device industry
• Knowledge and experience with a certified quality system, ISO 13485:2016 and/or FDA QSR 21 CFR 820.
• Should be able to write simple correspondence and effectively present information in one-on-one and small group situations to customers, clients, and other employees of the organization.

Education Requirements High School diploma or equivalent.

Physical Requirements

• Frequent performing repetitive work
• Occasional lifting (max. 40 lbs.)
• Occasional carrying (max. 40 lbs.)
• Subject to physical hazards from moving equipment and machine parts
• Constant safety glasses
• Constant full PPE
• Frequent standing
• Occasional sitting, walking, pushing, pulling, reaching.
• Regular attendance in the office is required

What We Offer:

• On-the-job training and advancement opportunities
• Competitive hourly wage + shift differentials (2nd & 3rd Shift)
• Great benefits like health, dental, vision, life, and disability insurance; 401K and much more.
• Paid time off, sick time and holiday pay
• Employee Assistance Program/ Tuition Reimbursement

Monday to Friday, 7:00AM-3:30PM