Senior Quality Engineer

4 weeks ago


Edinburgh, United Kingdom Intellect Group Full time

📍 Location: Dalgety Bay, Scotland, United Kingdom🕒 Full-time | PermanentAn 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 responsibilitiesMaintain 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 experienceDegree 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.DesirableExperience 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.



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