More jobs:
Quality Engineer
Job in
San Diego, San Diego County, California, 92121, USA
Listed on 2026-03-04
Listing for:
MillenniumSoft, Inc
Full Time
position Listed on 2026-03-04
Job specializations:
-
Engineering
Quality Engineering, Biomedical Engineer
Job Description & How to Apply Below
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.
- 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.
- 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.
- 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.
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