Lead Design Quality Engineer - Medical Devices

Lead Design Quality Engineer - Medical DevicesConsidering applying for this job Do not delay, scroll down and make your application as soon as possible to avoid missing out.A global healthcare organisation developing complex, regulated medical devices is seeking a Lead Design Quality Engineer to play a key role in product development and lifecycle quality. Operating in a highly regulated, innovation-driven segment of the medical device market, the company brings clinically meaningful technologies to healthcare providers worldwide, where patient safety, compliance, and manufacturing excellence are essential.This is a senior, hands-on quality leadership role with real influence across design, risk management, verification and validation, and supplier engagement.The RoleThe Lead Design Quality Engineer provides technical leadership and hands-on support across the full design and development lifecycle of medical devices. Acting as the Quality voice within cross-functional teams, this individual ensures products are designed, validated, and manufactured in compliance with global regulatory and quality standards, while also mentoring and guiding other engineers.The role requires strong experience in medical device manufacturing, design controls, FMEAs, and applied quality engineering tools, combined with the ability to partner effectively with R&D, Operations, and external suppliers.Key ResponsibilitiesDesign Quality & LeadershipAct as the Quality representative on product and process development teams.Lead and ensure effective execution of design control activities, including design reviews, verification, validation, specifications, and documentation.Provide guidance to engineering teams on quality engineering methodologies and best practices.Coach and review work of junior quality engineers and specialists.Risk ManagementLead risk management activities throughout product development using FMEAs and related tools.Partner with design and leadership teams to identify, assess, and mitigate product and process risks.Verification & ValidationParticipate in the development and review of master test plans, traceability matrices, and validation strategies.Evaluate test protocols and reports to confirm regulatory compliance and technical adequacy.Support the creation, evaluation, and validation of product and process test methods.Manufacturing & Supplier QualitySupport design for manufacturability to ensure products can be consistently built and tested.Lead supplier quality activities, including new tooling qualification and PPAP.Participate in supplier selection and specification reviews.Define quality characteristics and inspection plans for components, subassemblies, and finished devices.CAPA & NonconformanceLead or support investigations into complex product issues and nonconformances.Drive root cause analysis and corrective actions aligned with quality system requirements.Evaluate and disposition nonconforming materials used in pilot and clinical builds.Regulatory & ComplianceEnsure compliance with FDA and international medical device regulations and standards.Maintain current knowledge of applicable regulatory requirements.Represent the organization during FDA, notified body, and internal audits as required.Continuous ImprovementIdentify and lead opportunities for process and system improvements across functions.Promote continuous improvement in design control execution and use of quality tools.Apply statistical methods to analyze data and support decision-making.What They're Looking For7+ years of experience in Quality Engineering within the medical device industry.Strong understanding of medical device manufacturing, design control principles, and risk management (FMEAs).Proven experience leading cross-functional teams in a regulated product development environment.Solid working knowledge of FDA and international regulatory standards.Strong analytical, problem-solving, communication, and technical writing skills.Bachelor's degree or higher in Engineering, Science, or a related field.ASQ Certified Quality Engineer (or equivalent) strongly preferred.Experience in women's health or related therapeutic areas is a plus.Compensation & BenefitsCompetitive base salary aligned with senior medical device quality leadership roles10% annual bonusExceptional benefits package typical of a global healthcare organisation, including comprehensive health coverage, retirement programs, and wellbeing supportOpportunities for long-term career growth within a values-driven, quality-focused organizationServices advertised by Gold Group are those of an Agency and/or an Employment Business. xjdpvnf We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website

Created: 2026-01-31