- Champion Collaboration. Actively engage with data analysts, medical safety, manufacturing, and technical team members across the organization to ensure evaluation of product risk considers multiple inputs.
- Evaluate Risk. Aggregate and analyze data from multiple sources (e.g., complaints, manufacturing, medical safety, signal detection) and identify common trends.
- Present Assessment. Prepare presentations and reports to document the outputs of risk management monitoring activities.
- Escalate Risk. Use sound judgement to identify novel events, new risks, and changes to the risk profile; make recommendations to escalate or provide rationale regarding why escalation is not necessary.
- Update Risk Documents. Maintain Risk Management Files (RMFs) for commercial devices and combination products, including updates to Risk Management Plans/Reports, FMEAs, Hazard Analyses, User Risk Assessments, Design Risk Assessment, and Process Risk Assessments.
- Customer Focus. Proactively engage in championing best practices to drive a best-in-class Risk Management system. This could include actively reviewing clinical data, literature, and standards for state-of-art practices, then making recommendations to minimize product risk for patients.
- Degree in engineering, physical, or life sciences. Minimum education and experience requirements: Bachelor’s degree: 3 years of experience o Master’s degree: 1 year of experience
- Technical knowledge in a scientific or engineering discipline
- Working knowledge of 21 CFR Part 820, ISO 13485, EU MDR, and ISO 14971
- Working knowledge of Design Controls and development of RMFs/FMEAs
- Experience supporting Quality Systems/Quality Assurance/Quality Engineering functions or related field (e.g., regulated GxP environment in qualification/validation, documentation, or compliance) in a regulated biotechnology industry: medical devices, and/or combination products, and/or drug products
- Ability to interpret scientific data, perform basic statistical analysis, and present the results to both technical and non-technical audience in a relevant format, including basic pivot tables and graphs
- The ability to recognize problems and take corrective measures
- Strong attention to detail
- Analytical, organized, with strong multitasking abilities
- Fluent in verbal and written English
- Working knowledge of ISO/TR 24971, and/or ICH Q9
- Experience with device design and development and related risk files
- Experience with EN ISO 22242-1, IEC 62304, IEC 62366-1
- ASQ CQE or Risk Management certification
- Experience interacting with regulatory agencies
Significant Work Activities: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Type: Experienced