Document Control Specialist

Tegra Medical is seeking a Document Control Specialist to join 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 document change process and applicable databases.

• Ensure completeness of the storage, revision, integrity of the record and proper approval for all Quality documents and records

• 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 sign-offs.

• 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.

• Issue Return Authorization to customers for job returns that are approved.

• Maintain Employee Training requirements in Unipoint database. Enter completed training. Create Training sign-off reports for new and transferred employees and send to the applicable Supervisor. Create training sign-off reports for document updates.

• Other duties as assigned

Level of Skill, Education and Experience

Required:

• High School diploma or equivalent

• 2 years related experience.

• Must be able 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.

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