Job Opportunity

Reference: QS01017
Title: Senior Quality Systems Engineer
Location: Homebased
Job Type: 3 months contract
Salary: The PAYE rate is £43.17 per hour
Contact Person: Miss Rashida Khan apply@qualitystart.co.uk

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 when needed.

Skills: To apply for the role of Senior Quality Systems Engineer you will have the following:

• 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: In order to apply for this vacancy please ensure you have read and agree to the privacy policy found here and then email your CV to apply@qualitystart.co.uk quoting the reference number and the job title.