Quality Engineer (all genders) - limited until 30.09.2026
at Sanofi US
Waterford, County Waterford, Ireland -
| Start Date | Expiry Date | Salary | Posted On | Experience | Skills | Telecommute | Sponsor Visa |
|---|---|---|---|---|---|---|---|
| Immediate | 19 Jan, 2025 | Not Specified | 19 Oct, 2024 | N/A | Good communication skills | No | No |
Required Visa Status:
| Citizen | GC |
| US Citizen | Student Visa |
| H1B | CPT |
| OPT | H4 Spouse of H1B |
| GC Green Card |
Employment Type:
| Full Time | Part Time |
| Permanent | Independent - 1099 |
| Contract – W2 | C2H Independent |
| C2H W2 | Contract – Corp 2 Corp |
| Contract to Hire – Corp 2 Corp |
Description:
Responsibilities:
- Establish and maintain the global device risk management processes.
- Perform risk management according to ISO 14971 (risk management planning, hazard and harms list, Risk management reports…) and assists medical device sites in ensuring that risk management is performed in sufficient detail and in a timely manner for new device introductions and regulatory agency inspections.
- Ensure that project teams utilize appropriate risk analysis tools to assure that the Risk Management requirements are met.
- Develop and deploy appropriate Risk Management training for various internal and external Sanofi functions.
- Provide appropriate support to remediation of risk management files.
- Provide expertise and guidance to ensure a harmonized approach for all development and lifecycle management programs and perform Risk Management activities aligned with ISO 14971 including the update to Risk Management File based on post-market surveillance.
- Partner with other quality, compliance, development, and manufacturing groups to enable transparency, escalation, and action to resolve patient-safety-related issues.
- Establish and maintain linkages to other relevant risk management groups within Sanofi (e.g. Quality Risk Management, Technical Committee).
- Interface with network sites for device RMF-related topics
- Oversee trend outputs of market complaints within the network to identify possible multi-site impacts and implement the required corrective and/or preventive actions. If new risks are identified (failure modes) requiring an update of the risk analyses (pFMEA, dFMEA, use FMEA), notification of the impact to network sites.
- Interact with internal and external teams (engineering/product development /regulatory/ suppliers) to define the plan, timelines and strategy for development of the Clinical evaluation reports
- Support implementation of Design Controls elements per relevant procedures for new product development or design changes including Design History File (DHF) Maintenance
- Support Supplier Quality Engineering activities
- Support continuous improvement of projects or activities.
- Provide quality engineering support for Manufacturing Technology activities (includes but not limited to validation, transfer, supplier selection, and quality control plan)
- Perform Impact Assessment of change controls (components, products, platforms, and processes)
REQUIREMENT SUMMARY
Min:N/AMax:5.0 year(s)
Pharmaceuticals
Pharma / Biotech / Healthcare / Medical / R&D
Clinical Pharmacy
Graduate
Proficient
1
Waterford, County Waterford, Ireland
