Job Title: Quality Engineer
Salary: £40 - £45k
Hours: 9-5 Monday- Friday
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.
Main duties and responsibilities
- 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
Skills and experience sought
- 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
- Analytical skills - Ability to interpret data, spotting trends and planning corrective actions
- Organisational skills - Track testing results, documentation, and recommendations
- Excellent written communication - concise and accurate written documentation is essential. Also required to review internal and external guidance, and potentially write company SOPs
- Interpersonal skills - Able to provide training to staff on quality systems, working closely with manufacturing team members to find and eliminate errors in the processes
- Attention to detail - must be able to audit processes for non-compliance. Provide guidance and solutions for non-conformities. Ability to read and interpret the details of external guidance and industry regulations
- Critical/logical thinking - Ability to identify problems and solutions to ensure efficiency and quality of the manufacturing process
- 25 holidays Jan-Dec
- Pension - It is a NEST arrangement
- Employee contribution is 5%
- Employer contribution is 3%
- Employees can make 'Additional Voluntary Contributions' (AVCs).
- Flexitime working arrangements
- Post completion of probationary period
- Vitality single private healthcare
Closing date: 10.04.2022
Hawk 3 Talent Solutions are committed to the selection, recruitment and development of the best people, basing judgements solely on suitability for the job. Whilst we endeavour to respond to all applications individually, due to high volumes, this is not always possible. Thank you for your interest in this role and we look forward to working with you in the future