Cure Talent are delighted to be working with an exceptional International Medical Device Manufacturer who, due to their continued growth, have a superb opportunity for a Quality Engineer to join the team.As the new Quality Engineer, you will take ownership of assigned areas of the QMS, driving improvements, maintaining compliance with ISO 13485 and ISO 14001, and supporting the QA/RA team and wider business on quality-related matters.To be successful as the new Quality Engineer, you will have proven experience in Quality Assurance in highly regulated manufacturing, a strong understanding of ISO standards, expertise in using quality investigational tools, and experience conducting internal and supplier audits.Key responsibilitiesSupporting quality-driven, technology-focused projectsDeveloping and updating QMS procedures and associated documentationConducting internal and supplier auditsManaging and implementing CAPAsPerforming gap analyses for standards and regulationsSupporting product risk assessmentsDriving continuous improvement projects with a focus on sustainabilityProviding QA support for new product development and design changesThe ideal candidate will have the following skills and experience:Proven experience in a Quality Assurance role within a highly regulated manufacturing environmentKnowledge of ISO standards i.e. 9001, 13485, 9100, 16949 Experience with CAPAs, risk management and quality investigational toolsCertified Internal Auditor Ability to work independently on key projects and mentor team membersStrong communication and problem-solving skills, with the ability to influence stakeholdersIf you're looking for an exciting opportunity to be part of an established, market leading Medical Device company, get in touch now.