Senior Quality EngineerExciting medical device client due to strong growth are seeking to hire an experienced senior quality engineer with a strong emphasis on design assurance.Please note the person will need to be three days office based onsite mandatory.Design Assurance and Verification:Ensure design teams comply with internal procedures and regulatory standards for medical devices and device constituent part of combination products.Review and approve all design documentation: design inputs, outputs, risk assessments, and design verification and validation protocols.Ensure alignment of testing protocols with design requirements.Manufacturing for Clinical Supply:Collaborate with manufacturing teams to ensure the successful transition of devices from design to clinical production.Provide quality oversight in the manufacturing of clinical batches, ensuring compliance with internal procedures and regulations/standardsSoftware & Electronics Compliance (ISO 60601):For the candidate with a strong software and electronics background, support design teams in ensuring compliance with IEC/ISO 60601 standards for electrical and electronic medical devices.Approve software validation and participate in software design reviews.Risk Management and Process Validation:Ensure risk management activities are in accordance with ISO 14971, ensuring product safety and effectiveness.Approve internal and external processes related to device manufacturing, including process qualification and validation reports.Supplier Quality Management:Liaise with suppliers and external partners to ensure their processes and materials comply with quality and regulatory standards.Conduct supplier audits and assessments as needed to maintain compliance.Statistical Analysis and Process Improvement (Six Sigma):Use strong statistical analysis skills to evaluate product/process data and identify opportunities for design/process improvements.Implement process improvements to enhance product quality and efficiency, leveraging Six Sigma methodologies.Auditing and Compliance:Lead or participate in internal and external audits (e.g., ISO 13485, UK and EU MDRs, FDA QSR) to ensure compliance with regulatory requirements.Support/lead CAPA (Corrective and Preventive Action) processes, including root cause analysis and implementation of corrective actions.Cross-functional Collaboration:Work closely with cross-functional teams including R&D, manufacturing, and regulatory affairs to ensure timely delivery of quality objectives.Ensure alignment with project timelines, providing quality input during design and development reviews.General Profile Requirements:Experience:Minimum 5-10 years in medical device or combination product industries with a focus on design quality and assurance.Regulatory Knowledge:Strong understanding of relevant regulations and standards, including ISO 13485, EU and UK MDRs, ISO 14971, FDA 21 CFR Part 820, 21 CFR Part 11 and, ideally, ISO 60601.Technical Expertise:Design assurance expertise, particularly in device design, verification, and risk management.Skills:Strong problem-solving skills, statistical analysis (Six Sigma Black Belt preferred), auditing experience, and process validation knowledge.Flexibility:Ability to travel to other sites or suppliers when necessary.