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Quality Engineer

£35,000.00 to £40,000.00 per year
Edinburgh City Centre
Hays Specialist Recruitment

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Quality Engineer based in Stirling for an exciting new opportunity

Your new company
An exciting opportunity for this medical technology company based in Scotland who develop, manufacture and market smart connected diagnostics equipment solutions.

Your new role
Reporting to a Senior Quality, the successful candidate shall be responsible for providing support to the QA team in managing the day to day QMS activities associated with the production of IVD sensors (assays). Activities including but not exclusive to record reviews; coordination of documentation updates; archiving of quality records; coordination of corrective action closure and updating quality system information. Effective communication with The Client personnel both within and outside of the Quality Department will be required.

What you'll need to succeed
* Providing quality advice and support to other departments within the CLIENT organization
* QA review of records including quality events, planned deviations, corrective actions, customer feedback, protocols, risk assessments and supplier issues
* QA review of records associated with commercial and/or validation batches including the collation and archiving of all relevant batch records as part of Device History Records
* Update and maintain Device Master Records
* Execution of internal audits
* Collation and provision of data for external audits
* Coach and support in the writing of procedures, instructions, protocols, risk assessments and specifications
* Collation of data to support the generation of Quality Metrics and KPI's
* Support supplier approval and monitoring activities including supplier audits
* Prepare and create documents and records for upload on to the document management system
* Review and approve change controls as Quality representative on project teams and QMS

Essential skills
* Knowledge and experience of working to the appropriate quality and regulatory standards in a regulated industry
* Experience of working in a relevant role with a strong quality focus and with a minimum of 2 years' experience
* Scientific background
* Competent IT skills in EXCEL; POWERPOINT; WORD and ability to pick up new systems (eg document management; complaint; ERP systems)
* Excellent attention to detail
* Good team worker
* Excellent organizational skills for working on and prioritizing multiple activities
* Ability to use problem-solving tools and methodologies

Desirable skills
* Knowledge and experience of ISO13485, FDA 21 CFR Part 820, MDSAP
* Experience of post-launch IVD or medical device activities in a quality role
* Specific relevant experience eg complaint investigation, batch review/release, process validation
* Degree preferred
* Trained auditor
* Continual Improvement mindset (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping)

What you'll get in return
An excellent salary and package as well as joining a fast growing business that is thriving in the current market. Opportunity to grow your career and assist in the development of your team

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career.

Hays Specialist Recruitment Limited acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found at hays.co.uk

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