Sr. Document Control Specialist

Company Description

Treace’s mission is to be the leader in the surgical treatment of bunions by establishing the Lapiplasty® System as the standard of care. We are committed to operating our business with the highest standards of ethical conduct. We intend to exceed our customers’ expectations through an innovation-driven, high-velocity approach to solving treatment and surgical problems. With our products and services, our mission is to assist foot and ankle surgeons in improving patient outcomes and reducing healthcare costs, while providing rewarding experiences and opportunities for our employees and stakeholders.

Job Description

As the he Sr. Document Control Specialist will be responsible for supporting Quality System documentation, shall have prior experience working within an FDA compliant Title 21 section 820 environment, and has the ability to work cross-functionally to support rapid growth and continuous improvement.  Primary responsibilities include orderly recording and keeping of electronic documents, including data entry and transfer of documents within electronic data management system.

PRIMARY DUTIES AND RESPONSIBILITIES:

• Responsible for administration functions and maintains SolidWorks Product Data Management (PDM) system; processes quality system, marketing collateral, and product document engineering change orders
• Issues document and part numbers as requested by engineering and quality
• Electronically marks up documents for change processing (i.e. track changes)
• Distributes documents for approval and obtains signatures from team members
• Reviews, organizes, scans, and files paperwork electronically and physically
• Scanning, photocopying, faxing, printing
• Supports administrative functions and maintenance of quality system training (new hire, ongoing, annual, etc.) activities in eLMS (Absorb), as needed
• Assists with quality documentation and reviews, as necessary (i.e. complaints, calibration, training, etc.)

Qualifications

High School Diploma or equivalent preferred. 4+ years document control or similar record keeping experience.

Additional Information

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

Treace's Privacy Policy

It is Treace’s policy not to discriminate against any applicant for employment, or any employee because of age, color, sex, disability, national origin, race, religion, veteran status or any other characteristic protected by applicable law.

Treace is a drug free employer.