Senior Quality Systems Engineer
1 week ago
**Senior Quality Systems Engineer - Homebased**
**Opportunity**:
Are you currently upgrading Quality Management Systems to transition to the new MDR regulation? Do you have experience in dealing with NC/CAPA and of change control documentation? Have you drafted/customised and implemented 3rd and 4th tier documentation(work instructions and templates/forms)? Looking for your next contract role based working from home with an exciting global medical device company? If yes then this is the role for you.
Your role as a Senior Quality Systems Engineer based working from home will involve being part of the team of upgrading the companies QMS to transition to the MDR and to address the effectiveness of key systems.
You will deal with the backlogs of NC/CAPA and of change control documentation. You will also support in drafting/customising and implementing 3rd and 4th tier documentation (work instructions and templates/forms).
The focus on the role is for the following specific tasks:
- Co-ordinating the progress of open NC/CAPA to closure by liaising with process owners.
- Co-ordinating the completion of documentation and closure of open change requests by liaising with process owners.
- Reporting on the progress of clearance of backlogs to management.
- Supporting the Head of QA/RA in the remediation of QMS documentation for compliance with incorporated requirements and transition to MDR.
- Communicating with External Suppliers to address matters of quality or compliance.
- Supporting of the companies training system.
- Providing support during and prior to regulatory audits.
- Direct writing and review of company procedures, forms and work instructions to ensure compliance, efficiency and clarity.
This is a 3 months contract role which will be reviewed for a possible extension or go permanent but everything is dependent on the individual and business performance. There will be occasional travel to their site in Brownhills, West Midlands as and whenneeded.
The PAYE rate is £43.17 per hour.
**Skills**:
- Experienced senior quality systems engineer with medical device experience (essential), preferably with electromechanical devices or higher risk devices.
- MDR training and experience is held internally so MDR experience is not essential. It would be a good opportunity for a quality professional who does not have this to pick it up.
**How to Apply**:
If this sounds like the role for you or a colleague then please don’t hesitate to contact us. If we manage to successfully fill a permanent placement from your recommendation then we will send you a cheque of £300. We also have many incentive schemes forreferring contractors/temp staff so please contact us with the referral and we can provide you with more information.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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