Lead quality strategy for innovative life-changing medical technology Own risk management and design controls across the product lifecycle About Our Client Our client is an innovative medical technology company dedicated to advancing therapies that improve patient outcomes and quality of life. With a strong culture of collaboration, scientific excellence, and regulatory compliance, they offer employees the opportunity to make a meaningful impact on healthcare while working alongside industry experts. Job Description Serve as the Quality representative on cross-functional product development teams. Lead Design Control activities and ensure compliance throughout all development phases. Maintain and verify Design History Files (DHF) and support Device Master Records (DMR). Drive Risk Management activities including risk assessments, risk management plans, and risk reports. Collaborate with Engineering, Regulatory Affairs, Clinical Affairs, and Manufacturing teams to ensure product compliance. Review and approve engineering change orders and associated risk documentation. Author, review, and maintain quality procedures, technical documentation, and quality records. Support validation activities and ensure compliance with GMP and industry standards. Investigate non-conformances, complaints, and quality events using structured quality engineering tools. Lead corrective and preventive action (CAPA) activities through closure. Support internal audits and continuous improvement initiatives. Deliver training and guidance on quality systems, risk management, and quality engineering practices. Monitor post-market product performance, identify trends, and recommend corrective actions. Ensure ongoing compliance with

ISO 13485, ISO 14971, FDA

regulations, MDSAP, MDR, and other global requirements. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans, and all other qualified applicants. MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants. The Successful Applicant Bachelor's degree in Engineering, Life Sciences, or a related technical discipline. 4+ years of experience within the medical device industry or another highly regulated environment. Strong background in Quality Engineering, Quality Assurance, Risk Management, or Product Development. Expertise in Design Controls and

ISO 14971

Risk Management. Working knowledge of

ISO 13485, FDA 21 CFR

Part 820, MDSAP, MDR, and related regulations. Experience facilitating cross-functional risk assessments and product development activities. Strong analytical, problem-solving, and investigation skills. Excellent written and verbal communication abilities. Demonstrated ability to manage multiple priorities with minimal supervision. Proficiency with Microsoft Office and quality documentation systems. What's on Offer Direct visibility with senior leadership and product development teams. Opportunity to influence next-generation medical technologies. High-impact role with ownership of critical quality and risk management processes. Cross-functional collaboration across engineering, clinical, regulatory, and manufacturing groups. Strong career growth potential within a rapidly evolving medical device organization.