Quality Associate

1 week ago

Alloa, United Kingdom BioTalent Full time

**Introduction**

My client is a innovative medical devices company based in Scotland. They are aiming to change the face of many healthcare sectors including Oncology and Cardiology. They are expanding their teams an looking for a Quality engineer to join their team

**This role will offer you**:

- Flexible working start and finish times
- Opportunity to part of a rapidly expanding medical devices company
- Other benefits such as a bonus and medical insurance

**You will be responsible for**:

- Assist in the investigation and documentation of complaints, non-conforming product and CAPA
- Support supplier approvals and a manage outsourced projects
- Develop medical systems in accordance with the the appropriate regulations and quality standards
- Create, maintain and evaluate product/process trend to improve product quality
- Support in risk assessment activities ensuring compliance with ISO14971 and QMS training activities
- Perform validation activities for products that require validation

**You will bring the following**:

- Experience of working with quality and regulatory standards including ISO13485
- Understanding of design control and validation
- Familiarity with ERP, electronic document control systems and CAPA
- Trained in risk management
- Driver's license

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