Quality Specialist - West Midlands
Quality Specialist / Career Progression / QA Specialist / Quality Assurance Specialist
Location: West Midlands
Salary: Circa £35,000 plus benefits (potentially flexible for someone more experienced
A West Midlands based Medical Device Manufacturer are seeking a Quality Specialist to join their team on a permanent basis. This role will have a development path to grow and expand within the organisation and lead into management.
It is a well suited role for someone looking for that opportunity to have outlined progression which is quite often not available or mapped out within a company.
Role and Responsibilities:
- Carrying Out internal audits
- 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
- Capturing product changes and/or improvements through quality processes and ensuring product technical files remain robust
- Driving timely and appropriate closure of CAPA
- Manage product quality issues, defining & coordinating corrective & preventive action plans through to resolution
- Involvement in design verification & validation, generating of summary reports for inclusion in technical files
- Experienced in overseeing change control, quality issues and CAPA
- Working knowledge of ISO 13485 & ISO 9001
- Compliance with Internal & External Quality Audits
- Compiling technical files to support CE & FDA submission
Apply ASAP as interviews can be arranged for the end of this week. Send your updated CV through to and call Renee on to discuss further.
ISO 13485 / Medical Devices / CAPA / Technical Files / ISO 9001 / Validation / CE Marking / FDA