Description
My client is an Electromechanical Mechanical Medical Device company based in the West Midlands. They are now looking for a Quality & Compliance Manager (£50,000) to help support the gap between R&D/Product Development and Production.The Quality & Compliance Manager will be a pivotal member of the team, working with all departments to secure and maintain quality & regulatory compliance across the product range. The successful candidate will essentially "own" the company quality management system, with responsibility for:
- Providing compliance expertise to design teams
- Compilation of design history files & technical files
- Defining the appropriate level of verification and validation testing and compiling test results into summary reports
- Managing product risk management process through all lifecycle activities
- Co-ordination of new product compliance test activities including coordinating of external test facilities (LVD Safety Testing, EMC etc.)
- Capturing product changes and/or improvements through quality processes and ensuring product technical files remain robust
- Manage product quality issues, defining & coordinating corrective & preventive action plans through to resolution
Deliverables;
- Continued compliance with all regulatory requirements and adherence to declared ISO standards
- Ensuring new product technical & regulatory requirements are satisfied and signed off as appropriate for successful technical file submission and product release
- Compliance with Internal & External Quality Audits
- Hands on involvement in design verification & validation, including generation of summary reports for technical file submission
- Experienced in conducting investigations, managing change control, deviations and non-conformities, quality issues and CAPA
- Experience in document control software and systems
- Familiarity with software management and compliance to regulation
Experience Required;
The successful candidate is likely to be Degree qualified in an engineering discipline with at least 5 years' experience in similar roles within a regulated industry or compliance test lab environment.
- Hands on involvement in design verification & validation, including generation of summary reports for technical file submission
- Experienced in conducting investigations, managing change control, deviations and non-conformities, quality issues and CAPA
- Experience in document control software and systems
- Familiarity with software management and compliance to regulation
- Thorough understanding of quality and risk management systems
- Good organisational ability
- A logical & systematic approach to problem solving
- Excellent communication skills
- Hands on mechanical/electrical background
- Ability to effectively plan and manage own time and prioritise work to achieve agreed objectives
My client is looking to interview as soon as possible so if you believe you have the correct experience then please send me your CV and I will get in touch shortly.