Job Description
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
1. Maintain and enhance the Quality Management System (QMS) in line with ISO 9001 and ISO 13485 requirements.
2. Plan, conduct, and document internal and supplier audits, and act as the main contact for external audits, including customer, regulatory, and certification bodies.
3. Oversee document control processes, ensuring all procedures, work instructions, and records are properly maintained and up to date.
4. Support regulatory compliance with applicable standards such as FDA 21 CFR Part 820 (Quality System Regulation).
5. Collaborate with manufacturing and engineering teams to strengthen process quality and implement effective quality control measures.
6. Lead and participate in CAPA activities, driving root cause analysis and implementing corrective and preven...