|Salary||£45k - 52k per year|
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.