Quality Engineer II with a focus on ensuring quality, compliance, efficiency, and scalability as the company transitions from development to commercial stage. What You Will Do: Work as part of the Quality team in the overall support of design and manufacturing activities, through the introduction of new technology/techniques, skill development, training, process optimisation and cost saving projects. Provide specialist quality and technical engineering support to all departments. Support the maintenance, management and improvement of our Quality Management System in accordance with ISO 13485 and other applicable regulations. Monitor companywide training programme and compliance. Provide guidance, coaching and training to other employees within job area. Set high standards and drive accountability in the execution of responsibilities and model ethical behaviour. Participate in cross-functional teams and continuous improvement process efforts through corrective and prevention actions to solve problems or drive efficiencies. Set objectives for own job area to meet the objectives of projects and assignments. Contribute to the completion of project milestones. Support regulatory activities to ensure successful completion of market approval submissions to FDA and other regulatory bodies. Report progress against agreed timelines at meetings with management. Continually look for opportunities to optimise processes. Participate in internal/external audits as required. Participate in job-related training courses. Experience Requirements - The Ideal Candidate Must Have: Level 8 degree or equivalent in relevant discipline (e.g. Engineering/Science /STEM/ASQ CQE). Minimum of 2 years relevant engineering experience within an ISO certified medical device company. Strong understanding of ISO 13485 standard, FDA Part 21 CFR 820 and other medical device regulation. Excellent problem-solving and root cause investigation skills. Proficient in using quality management systems (QMS) and MS Office Suite. Good documentation skills and attention to detail. Strong communication and organisational skills. Proactive approach to problem-solving. Ability to work independently with minimal supervision and cross functionally. Confident communicating with internal and external stakeholders. At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details. Privacy Policy: By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see Skills: Quality Assurance QMS Audits CAPA's Benefits: Work From Home