Document Control Specialist

Job Description:

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it.

Because that’s how we change the lives of patients for the better. And that’s how we create better together.

Job Title:

Document Review Specialist

Reports To:

Sr. Supervisor, Quality Assurance

Location:

Austin, TX

Business Unit Description:

Driven by Enovis’ desire to create innovative products that help improve quality of life and restore movement to those suffering from degenerative arthritis, Enovis Surgical® provides orthopedic surgeons with modern, patient-focused solutions for total joint arthroplasty. Partnerships with key surgeon consultants help provide advanced and proprietary patented solutions, including EMPOWR 3D Knee®, the only dual-pivot knee system on the market, and AltiVate Reverse® Shoulder, a market-leading system, based on the design principles of the RSP® Shoulder, which has demonstrated excellent clinical outcomes at 10 years.

Enovis Surgical offers surgeons and their patients a full range of primary and revision implants for hip, knee, shoulder, and elbow reconstructive joint surgeries, in addition to the tools and digital health technology needed in today’s changing healthcare environment.

Job Title/High Level Position Summary:

At Enovis™ we sweat the little things. We embrace collaboration with our partners and patients, and we glory in the grind of scientific excellence — with the goal of transforming medical technology as we know it.

Because that’s how we change the lives of patients for the better. And that’s how we create better together.

As a key member of the Document Review Team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Key Responsibilities:

• Workorder Final check for accuracy and completeness.
• Perform quality control/release testing on products after they are Sterilized.
• Perform visual inspection of Device History Records with better than 99.9% accuracy.
• Perform Document Review and Sterility Releases in accordance with the Food and Drug Administration (FDA), International Organization for Standardization (ISO) and other applicable regulations
• Perform document review, analysis, inspection, and archive Device History Records (DHRs)
• Identify, document, segregate, evaluate, and disposition non-conforming material
• Maintain compliance in a highly regulated environment for medical devices following Good Documentation Practices (GDP)
• Able to communicate findings effectively in oral and written form with the aim of improving processes.
• Work as part of a team, contributing ideas to improve processes.
• Collaborate cross-functionally with team members from areas including but not limited to Manufacturing, Procurement, Distribution, Engineering, Quality, and Regulatory Affairs
• Meet schedule and overtime requirements as needed.

Minimum Basic Qualifications: 

•              High school diploma or GED required.

•              2+ years of relevant experience required; experience with quality inspection in manufacturing/production environment is preferred

•              Strong visual acuity and attention to detail required

•              Ability to sit for extended periods of time required

•              Ability to lift and maneuver up to 30lbs regularly required

Travel Requirements:

• <5%

Physical Requirements:

• Lift, carry, pull up to 50 pounds.
• Stand or sit for extended periods of time.

Desired Characteristics:

• Customer Focused
• Action Oriented
• Integrity and Trust
• Friendly attitude
• Problem solver
• Works well as both a team and individuals

“Creating better together”. It’s the Enovis purpose, and it’s what drives us and empowers us every day on a global scale. We know that the power to create better – for our customers, our team members, and our shareholders – begins with having the best team, pursuing common goals, operating at the highest levels, and delivering extraordinary outcomes.

Watch this short video and discover what creating better together means to us at Enovis:

 Our Enovis Purpose, Values and Behaviors on Vimeo

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