Quality Engineer 3

Roles & Responsibilities Lead cross-functional teams (engineering, design, commercial, product) to identify, evaluate, control, and document risks associated with medical devices. Develop, maintain, and execute comprehensive risk management plans throughout product development and sustaining activities. Oversee the implementation, verification, and validation of risk control measures. Lead periodic reviews of the risk management process to ensure ongoing effectiveness and compliance with our quality systems. Drive remediation efforts and implement FMEA processes for risk documentation updates. Conduct Benefit-Risk Analysis and evaluate residual risks using our acceptance criteria. Perform and document formal Risk Reviews and communicate outcomes to stakeholders. Ensure harmonization of risk management strategies across projects and lifecycle phases. Identify and implement opportunities for continuous improvement in the risk management process. Facilitate training and provide mentorship on risk management standards and practices. Support strategic planning and initiatives. Experience Required ~8+ years of experience in a regulated industry (medical devices, biopharma, or biotech), with strong preference for experience in similar organizations. ~5+ years of direct experience in leading risk management processes within the medical device industry, ensuring compliance and patient safety. ~ Experience with remediation and FMEA implementation is preferred. Skills & Certifications Expertise in risk management practices aligned with ISO 14971 and ISO 13485. Knowledge of IEC 60601 and IEC 62304 standards is a plus. Familiarity with automated dispensing devices like Pyxis is preferred. Strong data analysis skills using proprietary sources for risk probability calculation. Excellent communication and leadership skills to coordinate with global functional teams. Ability to drive cross-functional collaboration and continuous improvement initiatives. Proficiency in documentation and evaluation of risk management deliverables. Eligibilities & qualifications Bachelor’s degree in Engineering (Mechanical, Electrical, Materials, Biomedical, or a related field); Master’s degree preferred. Preferred certifications: ASQ Certified Quality Engineer, Certified Auditor, Six Sigma credentials.