Quality Engineer

Location - Gloucestershire

Salary - £45k - £52k

Job Type - Permanent

To maintain and support the quality management systems within a medical device ISO 13485, manufacturing environment.

Maintains product quality standards across all manufacturing processes, focusing on those where deficiencies are known/occur. Supports teams to work accurately and effectively to eliminate/reduce the probability and severity of faults, failures and scrap.

Working as part of a team which strives to define and develop manufacturing solutions from the early phases through to production working with the Engineering team. This will include working as part of a project core team with respect to design control, as well as working with the operational team on continuous improvement projects.

• Environmental monitoring control

• Reporting/completing of quality metrics monthly and filling out dashboard

• Supporting quality control team and monitoring performance and output

• Ensure quality is maintained across manufacturing

• Performing process validations

• 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

Qualifications & experience:

• 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

Omega Resource Group is acting as an Employment Agency in relation to this vacancy.