Job Title: Quality Engineer - QMS

Posted: 2019-10-30 17:33:46

Quality Engineer - QMS

Permanent Opportunity

Location – Stirling, Scotland

This is an opportunity to work with an exciting, energetic and growing IVD organisation. They have an excellent culture which is made of a team of proactive, talented, focused and enthusiastic individuals and are always looking for like-minded individuals to join their thriving team.

If you feel that you offer the same attributes and you would like to make a significant contribution to the continued growth and success of the company, then please get in touch today.

They are currently recruiting for a full time Quality Engineer who will responsible for providing QA support to the Stirling sites. Duties will include, but are not limited to batch review and release, Device Master Record updates, change control review & approval and quality event review & approval.

Role Responsibilities

  • Batch record review and product release

  • Device Master Record updates

  • Review of non-conformances, planned deviations and change controls

  • Prepare and create documents and records for upload on to documentation management system

  • Internal auditor

  • Identify and implement improvements to the QMS

  • Interact with all areas of the organization to ensure that quality processes and procedures are embedded

About You

  • You will have experience of reviewing batch records (or equivalent quality record)

  • Experienced in working with quality systems and processes (e.g. audit, non-conformance, CAPA, change control)

  • You will be experienced in both coordination and QA review of non-conformances and planned deviations.

  • You will have knowledge and experience of working to the quality and regulatory standards in a medical device, pharmaceutical or similar manufacturing industry with minimum 2 years’ experience in a relevant role.

  • You will be confident and experienced working within a dynamic and fast paced environment.

  • You will be a problem solver who is able to apply problem solving tools and methodologies

  • Ideally you will have knowledge and experience of working in a quality assurance role in medical devices and of the quality and regulatory standards ISO13485, FDA 21CFR Part 820.

  • It would be advantageous to have experience in immunoassays and molecular assays

  • You would ideally have a continuous improvement mindset (Kaizen, PDCA, Six Sigma, Lean, Value Stream Mapping)

  • Driving licence with own transport is essential

Further Details

Our client is offering a competitive salary in a great working environment therefore if you are looking to further develop your career with a thriving and growing company, this could be the role for you.

For more information, please call Shauny on 01382 938652 or e-mail a CV to shauny@entrustpeople.co.uk


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