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QARA Associate Specialist - Urgently Hiring!, Bridgend
Client: Zimmer Biomet
Location: Bridgend, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: 2b77100407d7
Job Views: 6
Posted: 22.01.2025
Expiry Date: 08.03.2025
Job Description:
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 recognized.
What You Can Expect
The QARA Associate Specialist will be responsible for supporting the Quality Assurance & Regulatory Affairs function within Zimmer Biomet's Sales and Distribution organisation for UK and Ireland.
How You'll Create Impact
Product Complaints
* Support local QARA team with managing Product Complaints
* Log complaints and forward them for ETQ (system) logging within the specified timeline
* Support follow up questions from Legal Manufacturers
* Work with After Sales team on servicing and repair complaints
* Provide reports and relevant data
Field Safety and Corrective Actions
* Support Field Safety and Corrective Actions process
* Work closely with FSCA Coordinator on FSCA initiation
* Manage FSN (Field Safety Notice) and complete administrative tasks associated with filing signed documentation
* Oversee return process
* Provide full reconciliation file
Quality Cage
* Conduct review on products currently held in the quality cage in the warehouse
* Review stock reports
* Work closely with warehouse staff to ensure all products are returned to the relevant Legal Manufacturer
General
* Support QARA Specialist with other aspects of Quality and Regulatory
* Liaise with other departments and team members at all levels worldwide
What Makes You Stand Out
* Organized and structured individual
* Ability to prioritise workload
* Ability to handle high volume of correspondence
* Work both independently as well as collaborate with stakeholders across the organisation
* Ability to prepare clear communication materials to the appropriate audience
* Discretion and confidentiality
* IT office skills: Outlook, Excel, PowerPoint, SAP SOP
* High standard of English / writing skills
Your Background
* Ideally experience in working with / within Quality functions in Medical Devices/ Pharmaceutical Industry
* Knowledge of ISO 13485 and Medical Device Regulations beneficial
EOE/M/F/Vet/Disability
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