Job Title: Quality Engineer - Development

Posted: 2019-11-27 17:10:36

Permanent Opportunity

Location – Stirling, Scotland

This is an opportunity to work with an exciting, energetic and growing medical device 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.

Role overview:

You will report to the Quality and Regulatory Director and be responsible for the day to day QMS activities associated with IVD instrumentation and software throughout the product life cycle including the R&D phase the verification and validation phase, manufacturing and product release.

You will be responsible for activities such as document/process creation, review and approval of documents and working with all project teams to guide the teams in the day to day use of the quality management system and to ensure applicable standards and regulations for the products being brought to the market are incorporated throughout the life cycle. 

Key responsibilities:

  • You will act as a quality representative for project teams throughout product life cycle and product realisation activities

  • You will be responsible for the creation and management of documentation forming the Design History File and Device Master Record. 

  • It will be your responsibility to assess, control and coordinate changes to the Design History File and Device Master Record.

  • You will coach and support in the writing of design requirements and specifications. 

  • You will coach and support in the writing of Verification and Validation plans and protocols

  • You will be responsible for the creation of tractability matrices.

  • You will organise, host and facilitate risk management related activities and design reviews with the project teams and ensure compliance of such activities to the applicable standards and regulations.

  • It will be your responsibility to ensure compliance of documentation for design partners (and suppliers) within the supply chain.

  • You will provide support on supplier approval and monitoring activities.

  • You will be responsible for preparing and creating documents and records for upload on to GAS. 

  • As Quality representative you will be responsible for reviewing and approving on project teams and QMS.

  • It will be your responsibility to review and approve Device History Records and final product release.

Essential skills:

  • You will have knowledge and experience of working to the appropriate quality and regulatory standards including ISO13485, FDA 21CFR Part 820.  

  • You will be experienced in working in an IVD or medical device environment with a strong quality focus and at minimum 2 years’ experience through development and verification and validation activities.

  • You will possess knowledge and experience in electromechanical medical device Hardware and software projects

  • You will have excellent organisational skills for working on multiple projects.

  • You will be able to use problem solving tools and methodologies.

  • You will be able to influence the internal project team and external parties to maximise success opportunities.

Desirable skills:

  • Ideally you will have specific experience working in quality within an R&D department of an IVD medical diagnostic device company.

  • Preferably you will have a science degree.

  • Ideally you will have a continual Improvement mindset and qualifications (PDCA, Kaizen, Six Sigma, Lean, Value Stream Mapping).

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