Quality Assurance Coordinator

4 days ago


Falmouth, United Kingdom Novus Recruiment Full time

Well respected company based in Falmouth, Cornwall are looking to recruit a permanent Manufacturing QA Coordinator

The role is responsible for maintaining quality standards and records throughout the manufacturing facility, reports to the Quality Manager.

**Duties**:

- Support for creation, implementation, and maintenance of Quality Management Systems (QMS) to meet the requirements of ISO 13485, FDA 21 CFR part 820, MDSAP, and relevant Directives and Regulations.
- Complaint investigation, monitoring and follow up as required.
- Creation, Maintenance and Control of Quality documents and records.
- Assist in the Preparation of Management Review, including monthly statistical trending.
- Perform final batch release sign off, Inspection & release of finished goods including ensuring quality records are maintained up to date.
- Support in Control of Device History Record, Design History File, Device Master Record
- Support with any other Quality related investigations and improvements as directed by the Quality Manager
- Escalate immediately to the Quality Manager in any case where potential risks are identified

Other duties:

- Support in improvement activities related to quality, quantity, and efficiency within all areas of the company
- Support that SOPs are written, well-documented and maintained, and that all employees are regularity trained on them
- Ensure that all company products are appropriately inspected and tested for conformance to applicable standards, regulations, and customer requirements.
- Generally supporting the Company's quality standards



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