Quality Engineer

QUALITY ENGINEER - Permanent Position - Ross-shire

We are working with a Ross-shire based manufacturing company who is looking to expand their Quality Team with an additional Quality Engineer.

A Graduate would be highly desirable for this role. Please note no sponsorship is available for this post.

Job Responsibilities

• Create, review and approve QMS documentation within business-required timelines.
• Support and manage the Quality Management System, including document control and record maintenance.
• Provide quality direction and support to other teams and the wider business.
• Support staff across functional areas in using key QMS processes and procedures, including document control and record maintenance, risk management, CAPA, and nonconformities (NCs).
• Deliver training on QMS topics as required, such as document control, risk management, CAPA, and NC processes.
• Support risk management activities as required.
• Support regulatory submission activities as required to enable global filings and registrations.
• Ensure completion of quality-related activities within agreed timelines and in accordance with compliance requirements.
• Participate in internal and/or external audits.
• Support technical file activities needed to obtain and sustain product approvals.
• Review product promotional materials, labelling, batch records, specification sheets and test methods for compliance with applicable regulations and internal policies.
• Adapt quickly and efficiently to changes in work and project priorities.

Required Skills & Qualifications

• Bachelor's degree in a Science or Engineering discipline (or equivalent experience).
• Minimum 1-3 years' experience in medical devices or a related field.
• Working knowledge of ISO 13485 and ISO 14971, with awareness of MDR and IVDR requirements.
• Solid understanding of GxP principles (including GLP, GCP and GMP as applicable to the role).
• Strong technical/procedural writing skills, including the ability to create, review and approve controlled documentation.
• Excellent communication and presentation skills, with confidence supporting cross-functional teams.
• Experience working both independently and as part of a broader project team.
• Ability to make decisions that affect own working practices and to support others in doing the same.
• Self-motivated, proactive "can-do" attitude with flexibility and adaptability to change.
• Willingness to travel within the UK and, on occasion, internationally.
• Competence in CAPA and nonconformity processes, including investigation support and quality follow-up.
• Practical understanding of audit readiness and audit participation.
• Ability to support regulatory and technical file activities, including document review and compliance checks.

Call to Action

If you're passionate about quality, compliance and delivering medical device products that make a real difference, we'd love to hear from you. Apply now by submitting your CV and any relevant details to be considered for the Quality Engineer role.

Brook Street NMR is acting as an Employment Agency in relation to this vacancy.