Risk Management Specialist
2 days ago
Best Buy Health is seeking a highly skilled Risk Manager to lead and maintain the risk management process for our health technologies. As a key member of our team, you will be responsible for ensuring compliance with ISO 14971:2019 and other applicable standards and regulations.
Key Responsibilities:- Lead the risk management process, ensuring all phases of product development consider potential risks.
- Identify potential hazards associated with both hardware and software components of medical devices.
- Perform risk analyses using FMEA (Failure Mode and Effect Analysis) and other tools to assess the severity, likelihood, and overall risk of identified hazards.
- Develop and implement risk control strategies to mitigate identified risks.
- Document all risk management activities thoroughly, including assessments, control plans, and residual risk justifications.
- Stay current with best practices and regulatory updates in medical device risk management.
- Support regulatory audits and inspections related to risk management.
- Bachelor's degree in a science, engineering, or related field required.
- Minimum of 5 years of experience in risk management required.
- Preferred qualifications include a Master's degree in a relevant field, experience in risk management for medical devices, and familiarity with software development methodologies.
Best Buy Health is committed to helping our people thrive at work and at home. We offer a range of benefits, including physical and mental well-being support, comprehensive benefits, and a generous employee discount.
We are an Affirmative Action and Equal Opportunity Employer dedicated to creating an inclusive environment that values the diversity of our employees. We do not discriminate against any employee or applicant based on race, color, religion, sex, national origin, age, disability, marital status, veteran status, sexual orientation, gender identity, genetic information, or any other protected characteristic under applicable law.
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