đź“Ť Location: Dalgety Bay, Scotland, United Kingdom
đź•’ Full-time | Permanent
An opportunity has arisen for an experienced Senior Quality Engineer to play a key role in maintaining and improving quality systems, ensuring products and processes meet the highest standards of compliance and customer satisfaction.
Key responsibilities
* Maintain and enhance the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 requirements.
* Plan, conduct, and document internal and supplier audits, and act as the main contact for external audits, including customer, regulatory, and certification bodies.
* Oversee document control processes, ensuring all procedures, work instructions, and records are properly maintained and up to date.
* Support regulatory compliance with applicable standards such as FDA 21 CFR Part 820 (Quality System Regulation).
* Collaborate with manufacturing and engineering teams to strengthen process quality and implement effective quality control measures.
* Lead and participate in CAPA activities, driving root cause analysis and implementing corrective and preventive actions.
Qualifications and experience
* Degree in Engineering or a related technical discipline.
* Minimum of 5 years’ experience in a Quality Engineering role within the Electronics Manufacturing Services (EMS) industry.
* Proven experience in roles such as Quality Engineer, Senior Quality Engineer, or Quality Manager.
* In-depth knowledge of ISO 9001 and ISO 13485 systems.
* Certified Lead Auditor for ISO 9001 and/or ISO 13485.
* Strong understanding of document control practices and QMS implementation.
Desirable
* Experience with FDA 21 CFR Part 820 (QSR).
* Six Sigma Green Belt certification.
* Familiarity with statistical analysis software such as Minitab.
* Strong communication, analytical, and problem-solving skills.
If you have a passion for quality and continuous improvement, and enjoy working in a structured yet dynamic environment, this role offers an excellent opportunity to make a meaningful impact.