Quality Engineer

About the Role We are looking for a Quality Engineer to join a Medical Device manufacturing company in North Wales. This is an excellent opportunity for a quality professional who is passionate about compliance, continuous improvement, and delivering products that make a meaningful difference to patients' lives. As a Quality Engineer, you will play a key role in ensuring our products and processes meet the highest quality and regulatory standards. You will work closely with manufacturing, engineering, R&D, and global quality teams to support quality management activities, investigations, risk management, and process improvement initiatives. What You'll Be Doing Supporting and improving the site's Quality Management System (QMS) Developing, reviewing, and maintaining quality procedures, work instructions, and records Participating in internal and external quality audits Supporting product and process quality activities throughout the product lifecycle Contributing to design reviews, verification, validation, and design transfer activities Supporting process validation activities (IQ/OQ/PQ) Conducting risk assessments and maintaining risk management documentation in line with ISO 14971 Investigating product and process non-conformities Leading root cause investigations and supporting CAPA activities Helping ensure compliance with applicable medical device regulations and quality standards Analysing quality data, trends, and performance metrics Leading or supporting continuous improvement projects using Lean Six Sigma methodologies Collaborating with cross-functional stakeholders to drive quality and operational excellence About You To be successful in this role, you will ideally have: A degree (or equivalent experience) in Engineering, Science, or a related discipline At least 2 years' experience in a Quality Engineering, Quality Assurance, or similar role Experience working within a regulated manufacturing environment Knowledge of Quality Management Systems (QMS) Understanding of CAPA and non-conformance processes Experience using data analysis tools such as Excel (Minitab experience is advantageous) Strong problem-solving and root cause analysis skills Excellent communication and stakeholder management abilities Ability to work effectively across multidisciplinary teams Knowledge of change control and validation processes would be beneficial Experience with FMEA or other risk management tools would be advantageous Six Sigma Green Belt qualification, or experience applying quality engineering tools and techniques, would be desirable Why Join Us? Be part of a global organisation that develops products which improve patient outcomes and quality of life Work within a collaborative and supportive quality team Gain exposure to medical device quality systems and regulatory requirements Opportunity to lead improvement projects and shape manufacturing quality performance Competitive salary and benefits package Career development and progression opportunities Guidant, Carbon60, Lorien & SRG - The Impellam Group Portfolio are acting as an Employment Business in relation to this vacancy