Note: The job is a remote job and is open to candidates in USA. Systems Ally is seeking a Risk Management Engineer to support medical device quality and regulatory compliance. The role leads product risk identification, evaluation, control, documentation, FMEA implementation, risk management reviews, post-market risk activities, training, and continuous process improvement.
Responsibilities
- Lead multi-functional discussions such as with engineering, design, commercial, and product teams to ensure that all hazards associated with products are identified, risks are estimated, evaluated, controlled, and documented. Monitor that risk controls are implemented, verified, and validated for products in development and verify the effectiveness of risk control measures throughout the product life cycle
- Maintain ISO 14971 compliant risk management files and serve as a subject matter expert in design control and post-market risk management process and execution
- Collaborate on design, development, and validation strategies, ensuring documentation aligns with Quality Management Systems compliance requirements
- Lead remediation efforts for updating risk management documents and the implementation of the FMEA process
- Perform and document Risk Management Reviews to communicate results of the risk management process to cross-functional teams
- Ensure harmonization of risk management strategies across projects and their lifecycle by communicating with other Risk team members
- Identify opportunities for continuous improvement of the Risk Management Process
- Facilitate and provide ongoing training on standards/processes as needed for other associates or functions
- Assist with strategic initiatives and planning
- Mentor and coach post-market risk management and cross functional teams on risk management processes
Skills
- • Bachelor's degree in engineering and 5 years of Quality, Design Controls, Risk Management experience within the medical device industry
- • Minimum of 5 years of Post-Market Quality, specifically complaint trending/data analytics and risk assessments
- • Advanced knowledge of risk management, design controls, regulatory, quality engineering polices, principles and standard methodologies
- • Advanced knowledge of FDA/ISO applicable guidance, regulations and standards including ISO 14971, ISO 13485, FDA 21 CFR 820
- • The position requires strong oral and written communication and interpersonal skills, technical problem solving, the ability to work in teams, critical thinking, the ability to adapt to a rapidly changing environment, and desire to contribute to meaningful and innovative products
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