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Document Control Specialist

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Job Location drjobs

Austin - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

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 thats how we change the lives of patients for the better. And thats 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 todays 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 thats how we change the lives of patients for the better. And thats 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. Its the Enovis purpose and its 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

We offer a comprehensive benefits package which includes:

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement global talent and innovation the Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and beyond. Visit to learn more.

EQUAL EMPLOYMENT OPPORTUNITY:

Enovis provides equal employment opportunities based on merit experience and other work-related criteria and without regard to race color ethnicity religion national origin sex age pregnancy disability veteran status or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement global talent and innovation the Companys extensive range of products services and integrated technologies fuels active lifestyles in orthopedics and more information about Enovis please visit .

EOE AA M/F/VET/Disability Statement

All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race religion color national origin sex protected veteran status disability or any other basis protected by federal state or local laws.


Required Experience:

Unclear Seniority

Employment Type

Full-Time

About Company

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