Quality Engineer

1 day ago

Gloucestershire, United Kingdom C4S Search Ltd Full time

**About the Company**

C4S Search are currently working with a healthcare manufacturing company. The company were founded in 1856 and are looking to expand their team.

This company have a great team already and are looking to add a Quality Engineer to their team.

**About the Role**
- To maintain and support the quality management systems within a medical device ISO 13485, manufacturing environment
- Maintaining the efficiency of the Quality Management System (QMS) and implementing continuous improvement
- Maintaining processes and creating procedures related to incoming inspection, quality assurance and quality compliance
- Work with the Technical teams to ensure the proper deployment of Engineering Changes
- Plan and carry out Process Validation for existing and new products
- Qualified as an internal auditor. Part of the internal quality audit team by auditing the quality and manufacturing processes to ensure both internal and external regulations
- Maintain working knowledge of Regulatory and Quality System requirements
- Support customer & 3rd party audits, including yearly QMS audit
- Writing and updating documentation for maintenance of the quality management system
- Contribute to CAPA system, complaint management process and documentation control
- Train and provide assistance to the other QA teams on quality procedures, protocols, and documentation
- Coordinate investigation of quality issues with customers and suppliers
- Assist with the monitoring, measurement and recording of environmental conditions significant to preservation of product and for packaging of product to be sterilised
- Leads Quality related projects and represents quality as and when required on projects across operations

**About You**
- Scientific or engineering degree with experience in the medical device or pharma industry, in a quality related position
- Certification, such as Quality Engineer, Quality Auditor, Six Sigma, or Quality Improvement Associate, is preferred
- Working knowledge of ISO 13485, 21 CFR 820, ISO 14971, Medical Device Directive 93/42/EEC, Medical Device Regulation 2017/745
- Project management desirable
- Formulating and execution of corrective action programs
- Superb computer competence, including experience with databases and Microsoft Office
- Knowledge of QA terms, tools, and methodologies

If this sounds like it could be of interest, please send your C.V through to C4S Search for consideration.

If this role is not the perfect fit for you please upload your CV to the C4S Search website, we have a number of technical vacancies currently that could be your next dream role

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