Risk Management Quality Engineer
Qualification: Bachelor’s Degree
Risk Management Quality Engineer needed to perform the following Job duties :
- Execute and support on-time completion of Risk Management Deliverables
- Maintain Risk Management deliverables to ensure continued acceptability of product based on post market feedback
- Support on-time execution of Quality Plans for internal development, OEM-based, Clinical Product Development (CPDP), and design change projects.
- Support Risk Management / Cybersecurity activities from product Concept through product obsolescence.
- Support DHF content completion, integrity, and regulatory & standards compliance; collaboratively communicating & resolving gaps
- Drive creation of risk mitigation strategy and support the establishment of objective, measurable, discrete, and verifiable customer and product requirements to meet that strategy.
- Complete Document Change Request Reviews in a timely and objective manner
- Additional duties may be identified by functional management based on the current project/business objectives.
- Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
- Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.
- Performs other related duties and responsibilities, on occasion, as assigned.
Bachelor’s Degree Required in Mechanical Engineering or Industrial Engineering or Industrial Management.