Quality Engineer

Our client Flex Medical Solutions are looking to hire an experienced Quality Engineer on a maternity cover contract. Flex Medical are based in Livingston.

FlexMedical Solutions (FMS), help customers bring their ideas to life and create a healthier tomorrow, by providing contract design, development, and manufacturing services to medical device OEMs

Reporting to the Senior Quality Engineer, day to day activities will include providing support and guidance of product and process Design & Development, and Validation & Verification activities. Cross-departmental communication and collaboration skills are essential to arrive at compliant solutions in an efficient manner. Additionally, the post holder will support/own Non-Conformance/CAPA investigations and assist during various audits.

The role requires strong experience of working to and interpreting ISO 13485:2016 and CFR 21 Part 820 to deploy creative solutions.

Key Responsibilities

  • Provide quality oversight for design controls and risk management activities.
  • Review and approval of equipment qualification and process validations (IQ/OQ/PQ) to meet regulatory and business requirements.
  • Assist Senior Quality Engineer in the maintenance of the electronic Quality Management System (eQMS), ensuring accurate documentation and adherence to standards and documented procedures.
  • Review and approve quality documentation, including but not limited to validation protocols/reports, change controls, and non-conformance reports.
  • Collaborate with cross-functional teams (R&D, manufacturing, regulatory, etc.) to ensure project timelines are achieved throughout product development and manufacturing.
  • Engage clients directly as and when appropriate regarding quality matters.
  • Provide support for audits and inspections by regulatory agencies, notified bodies, clients and internal audits.
  • Support colleagues and occasionally own planned deviations, Non-Conformance and CAPA investigations when appropriate.
  • Ensure compliance with relevant regulatory standards (e.g., ISO 13485 2016, FDA 21 CFR Part 820).

Knowledge, Skills & Experience

Essential

  • 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).
  • Extensive knowledge and experience of equipment and process validation (IQ/OQ/PQ) principles.
  • High proficiency with electronic Quality Management Systems (eQMS).
  • Understanding of design controls and the product development lifecycle.
  • Familiarity with relevant regulatory standards (e.g., ISO 13485, FDA regulations).
  • Excellent problem-solving skills.
  • Excellent written and verbal communication skill.
  • Demonstrable proactive approach to work.
  • Detail-oriented.

Apply above or reach out to me at ak@kleboejardine.com for a confidential discussion about the opportunity.