Tegra Medical is looking for a Document Control Specialist to join our Franklin 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:

• Manage document change process and applicable databases.
• Manage DHR documentation control including sending and retrieving records to the off-site storage facility.
• Perform job certification process on all production job shipments.
• 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.
• Issue Return Authorization to customers for job returns that are approved.
• Prepare procedures and work instructions in the appropriate format. Review documents for grammar and syntax before sending them for approval.
• Maintain document of revision levels of Quality documents.
• Review Order Launch entries to verify inspection documents match customer as well as internal specifications.
• Review Traveler Change Control request entries to verify inspection documents match customer as well as internal specifications.
• Manage Franklin calibration system.
• Manage and control external standards.
• Additional requirements as requested

Qualifications and Education Requirements:

Required:

• High School diploma or equivalent
• 2 years related experience

Desired:

• 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.

Physical Requirements:

• Ability to multitask in a fast paced environment
• Problem solving capability

We offer great benefits…

• Health, Dental, Vision and Rx insurance
• 401(k) contribution with Safe Harbor
• HSA and FSA spending accounts
• Apprenticeship programs and Tuition reimbursement
• Referral bonus program
• Company paid Life insurance and AD&D
• Short and Long term disability
• Vacation and Sick days
• 10 paid Holidays
• Employee assistance program
• Pet Insurance
• Profit sharing program
• Performance Bonus for eligible positions

Tegra Medical is an Equal Opportunity Employer
M/F/D/V