Risk Management SME #9350

15 minutes ago

San Diego, California, United States ECI Full time

Brief Description
About ECI
ECI's mission is to be the global leader of professional consulting services for the life sciences industry. Our clients lean on our diverse perspectives and decades of expertise to tackle their toughest challenges and we take pride in providing them transformative solutions with distinctive, sustainable and long term value. ECI boasts a proven track record of providing full product life cycle consulting on a variety of challenging and exciting projects. Our collaborative culture, welcoming team and flexible employment & benefit options allow us to maintain strong relationships with the most talented individuals in the life sciences industry.

About The Role
We are seeking an experienced Risk Management Subject Matter Expert (SME) to support quality system remediation efforts. The SME will serve as a key resource in evaluating and improving risk management programs to ensure alignment with applicable regulations and standards. The role involves assessment, planning, documentation, training, and implementation activities across quality and compliance systems.

What You'll Do
Risk Management Program Assessment and Support:

  • Serve as a subject matter expert in Risk Management processes and best practices.

  • Conduct gap analysis of the existing Quality Management System (QMS) and Risk Management programs, including:

  • Policies, procedures, work instructions, forms, and collateral documentation.

  • Quality and risk documentation and records for compliance with applicable regulations and standards.

  • Evaluate and assess existing QMS Procedures, work instructions, electronic process, and risk management files (RMFs), including records and documentation against 21 CFR 820 and ISO 13485.

  • Prepare and submit comprehensive Assessment Reports detailing findings and areas for remediation.
  • Develop a Quality Plan outlining corrective actions and improvement strategies to address identified gaps.
  • Implement, instruct, and train staff on Risk Management remediation directives in compliance with regulatory requirements.
  • Ensure all remediation efforts meet applicable regulatory and quality standards.
  • Interface and collaborate with other subsystems or teams to ensure alignment and integration of risk remediation activities.
  • Participate in meetings, reviews, and discussions to support ongoing compliance and continuous improvement.

What You Will Bring

  • Bachelor's degree in Engineering, Life Sciences, Quality Assurance, or a related field.
  • Minimum of 10+ years of experience in Medical Device Risk Management.
  • Strong knowledge of international standards such as ISO 14971, ISO 13485, FDA 21 CFR Part 820.
  • Proven experience conducting gap assessments and remediation planning.
  • Strong technical writing, communication, and project management skills.
  • Ability to work independently and as part of a cross-functional team.

ECI is an equal opportunity employer.
All qualified applicants will receive consideration for employment at ECI without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.
At the time of this posting, all candidates must be authorized to work in the U.S. without the need for employment-based visa sponsorship now or in the future. At the time of this posting, ECI will not sponsor applicants for U.S. work visa status for this opportunity.

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