QAra Associate Specialist

9 hours ago

Bridgend, United Kingdom Zimmer Biomet Full time

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**:
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
- Working closely with FSCA Coordinator on FSCA initiation
- Managing FSN (Field Safety Notice) and completing administrative tasks associated with filing signed documentation
- Overseeing return process
- Providing full reconciliation file

**Quality Cage**
- Conducting review on products currently held in the quality cage in the warehouse
- Reviewing stock reports
- Working 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 other 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 all 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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