We are looking to hire a dedicated Document Control Specialist to join our all-star team at Tegra Medical LLC in Franklin, TN.
Growing your career as a Full Time Document Control Specialist is an amazing opportunity to develop vital skills.
If you are strong in decision-making, creativity and have the right determination for the job, then apply for the position of Document Control Specialist at Tegra Medical LLC today!
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: 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.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.Additional requirements as requested. Level of Skill, Education and Experience Required:
High School diploma or equivalent2 years related experience.Must be able edit and format documents using Microsoft Office applications, i.e.Word, Excel and/or PowerPointDesired:
Experience working in a document control function in a manufacturing environment, preferably Medical device industryKnowledge 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. Competencies Attention to detailExcellent interpersonal skillsAbility to work under minimal direction and self-motivatedWe offer great benefits… Health, Dental, Vision and Rx insurance401(k) contribution with Safe Harbor HSA and FSA spending accountsApprenticeship programs and Tuition reimbursementReferral bonus programCompany paid Life insurance and AD&DShort and Long term disabilityVacation and Sick days10 paid HolidaysEmployee assistance programPet InsuranceProfit sharing program Performance Bonus for eligible positions Tegra Medical is an Equal Opportunity Employer
M/F/D/V
Benefits of working as a Document Control Specialist in Franklin, TN:
? Unlimited Growth Potential
? Opportunities to grow
? Generous Compensation
