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.