Zimmer Biomet

At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.

As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.

What You Can Expect

The Document Control Coordinator responsibilities include batch record review and release, documentation processing and handling and basic principles of quality systems. He/she will also be responsible for working within most aspects of the Quality System Regulations (QSR’s), such as 21 CFR 820 & ISO 13485 for medical devices.

How You'll Create Impact

Responsible for review of batch records, creating Certificate of Conformances for product release, assisting with document control and records management processes, and for ensuring records are processed, retained, and updated appropriately. Also responsible for assisting with ensuring change orders and documents are processed within a timely manner.

Responsible for review of production batch records and giving direction to team members regarding updates to batch records upon review. Duties and responsibilities include but are not limited to:

• Review of production batch records for accuracy, completeness and cGMP
• Documentation Control / Record Management
  • Configures and implements document change orders
  • Ensures appropriate justification is referenced per change
  • Review and accept/reject the impact assessment to the design change
  • Review and accept/reject the regulatory actions per the change
  • Identify and route document proposed changes to the approval group and manage the document routings through to publication
• Training
  • Schedule training per the document change order requirements
  • Assist with conducting QMS database functionality and responsibilities training
• Compliance
  • Assist Quality Management with ensuring conformance in accordance with the fundamental cGMP & GLP practices.
  • Maintain compliance to internal SOP’s, and any applicable ISO standards that Embody claims compliance to
  • Assist with the compilation and analysis of QMS metrics in support of quality objectives for Management Review
• Audit Support
  • Support Quality Management during internal audits
  • Support Quality management during external third-party audits
• All other duties as assigned

What Makes You Stand Out

• Comfortable working within a support function
• Good communication skills
• Personable and willing to work closely with people from diverse backgrounds
• Strong working knowledge of MS Office products (word, excel, etc.)
• Experience working with a QMS database preferred
• Familiarity with cGMP’s preferred

Your Background

• BS degree in any field of study from an accredited university preferred
• Minimum 3-5 years of experience in quality or a similar regulated industry preferred
• Strong attention to detail

EOE/M/F/Vet/Disability