Job DescriptionQuality Manager
12 Month Fixed Term Contract
We are currently helping a Medical Device company based in West Yorkshire to identify and appoint a Quality Manager on an initial 12 month contract.
The successful candidate will have excellent exposure to ISO13485 audit standards and will learn how to develop and manage Quality Management Systems within Medical Device Companies.
Our client is a growing Medical Device business with a global customer base, headquartered near Bradford. Our client design and supply some of the most innovative products in their field, manufactured to the highest quality standards across a global supply chain. Our client offer an excellent training and development plan and will invest time on the right applicant to help get them up-to-speed with the relevant 3rd party standards.
Whilst the job title is Quality Manager, the responsibilities for this opportunity might be a Quality Assistant or Assistant Quality Manager.
The successful candidate be responsible for maintaining the Quality Management Systems on-site, with specific awareness of:
- Ensuring continued daily compliance with ISO13485 manufacturing standards and keeping all relevant documentation up-to-date
- Maintaining CAPA documentation
- Completing Internal Audits
- Working on the MDD -> MDR transition project
- Managing customer complaints, including complaint investigation
- Assisting with preparation for an ISO13485 audit
The successful candidate doesn’t need specific Medical Device knowledge; however you will have a background within Quality Assurance and the transferable skills to begin to understand ISO13485.
Additionally, you will be able to demonstrate:
- Awareness of a similar ISO standard, such as ISO9001 or 14001 is essential
- Excellent attention to detail and an ability to solve administrative problems is essential
- Knowledge and experience of completing a 3rd party audit process is essential
- Experience of manufacturing process or supply chain/logistics is essential