Senior Quality Engineer

Our client is an innovative Scottish SME that provides contract design, development and manufacturing services to medical device OEM’s.

The business is going through a phase of exciting expansion and are seeking a talented and experienced Senior Quality Engineer to join their tight-knit team and play an active role in the company’s growth.

The role will provide support and guidance of Validation & Verification and R&D activities through design and development lifecycle phases.  This will involve exposure across the business with cross-departmental communication and collaboration to arrive at compliant solutions in an efficient manner.  The role requires strong experience of working to and interpreting ISO 13485:2016 and CFR 21 Part 820 to deploy creative solutions.

Additionally, you will have sole responsibility for one or more sections of the Quality Management System.  You will work cross functionally with other business areas and will be responsible for aspects of product quality.

Key Responsibilities

  • Act as quality lead on cross functional projects across all product lifecycle phases to ensure the proper application of design controls.  This includes leading technical reviews of design, documentation, test procedures and other deliverables.
  • Drive compliance through key input, timely review, approval and improvement across key project documentation including but not limited to:
    • Validation plans, protocols and reports
    • Design and Development Phase exit documentation
    • Specification generation
    • Non-Conformance and CAPAs.
  • Identify key technical challenges and offer recommendations by utilising Quality Engineering principles and problem-solving skills.  In order to carry this out successfully you must be able to communicate effectively across the business at all levels and externally to clients.
  • Be the SME and responsible member of the Quality team for one or more sections of the Quality Management System, for example NC & CAPA, Supplier Review & Approval.
  • Lead risk management activities and ensure consistency of approach and adherence to established operating procedures and regulations such as ISO 14971:2019.
  • Ensure ongoing compliance to ISO13485, FDA 21CFR Part 820 and any other regulations governing product. This includes being SME during internal and external audits.
  • There is potential, if not immediately, to manage/coach/mentor Quality Technicians/Engineers going forward.

Knowledge, Skills & Experience

Essential Requirements

  • Qualified in a scientific or engineering discipline, ideally to degree level, and with proven medical device industry experience (in lieu of academic qualification, we will consider candidates with significant experience in the medical device industry).
  • In-depth knowledge of ISO13485:2016 and CFR 21 Part 820, with good interpretive and analytical skills to effectively develop creative solutions to achieve and maintain their application.
  • Experience of working cross functionally and collaboratively to educate and support departments to  achieve cross departmental deliverables that are fully compliant with the standards.
  • Experience of Design and Development in the medical device industry.
  • Strong, demonstrable experience in product and process validation and verification.
  • Understand technical challenges and interpret technical information including drawings and specifications.
  • Experience in leading complex risk assessment activities.
  • Effective communicator, able to communicate QA deliverables and requirements in a clear manner.
  • Experience in quality systems including the use of EQMS.

Working for an organisation currently scaling will provide you with a fantastic opportunity to make your mark and implement your ideas. We are keen to find a key contributor to be part of our journey and the businesses’ continued success so get in touch to find out more!