What are the responsibilities and job description for the Subject Matter Expert Risk Management position at Aditi Consulting?
Payrate: $56.60 - $76.60/hr.
Summary:
This is a Subject Matter Expert role in Risk Management within the Design Quality Assurance team. The role involves performing gap assessments, planning, organizing, executing, and reporting all usability and risk management activities through collaboration with cross functional teams. This role is responsible for support of EU MDR remediation projects of varying scope and complexity. This individual will collaborate with internal design and development, regulatory affairs, medical affairs, and manufacturing engineering partners.
Responsibilities:
- Perform thorough gap assessment of existing usability and risk management documentation against EU MDR requirements and relevant standards, such as ISO 14971:2019 and IEC 62366-1:2015
- Provide risk management leadership, expertise, guidance, and supervision throughout the remediation project.
- Development of efficient and robust processes, procedures, practice, tools and technology to support continuous improvement in risk management.
- Leads development and implementation of key performance indicators and metrics for the risk management process.
- Support the post market surveillance team by creating Health Impact Assessments and Health Hazard Evaluations.
Qualifications:
- Bachelor’s Degree in Engineering (Mechanical, Chemical, Biomedical, Electrical)
- 5-7 years of experience of working within a medical device industry with subject matter expertise in the application of Risk Management (ISO 14971:2019) for all classes of medical devices
- Expertise in the application of statistical techniques to support the calculation of probabilities of hazardous situations occurring (p1).
- Expertise in industry best practices and advances in Usability Engineering and Risk Management practices, processes, tools and technology.
Desired Skills:
- Worker at an engineer level that will create content, developing design control.
- Need to have expertise in Risk and Risk Management
- Know ISO 14971
- Working knowledge of the usability standards.
- Protocol development
- Understanding of statistical methods and techniques
- Remediation of Risk management files and potentially creation of usability engineer files.
- Roll up their sleeves and work.
- Wants someone to fix the problem and not consult on what is wrong.
Pay Transparency: The typical base pay for this role across the U.S. is: $56.60 - $76.60/hr. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.
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Salary : $57 - $77