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Quality Engineer III
BlueRock Therapeutics. Provide end-to-end device quality support for drug-delivery and cell-delivery devices used in clinical programs .
About the role
Key responsibilities & impact- Provide end-to-end device quality support for drug-delivery and cell-delivery devices used in clinical programs
- Support downstream sustaining quality after design transfer
- Support trial readiness, lot disposition, complaint management and investigation, and quality oversight of CMOs and off-the-shelf device vendors
- Support device development activities under design controls as assigned
- Perform quality review and disposition of device batches and lots for clinical use
- Review device history records, certificates of conformance, and supporting documentation
- Own device complaint handling, including intake, evaluation, investigation, root cause analysis, trending, and closure
- Manage device-related quality issues at clinical hubs and sites, coordinating containment, investigation, and stakeholder communication
- Provide trial readiness support, including mock runs, site/hub readiness, and on-call support on the day of surgery
- Support deviations, nonconformances, and CAPAs related to clinical devices
- Evaluate and approve CMO and vendor process changes for impact on device quality, validated state, and clinical supply
- Lead or support operational improvement projects affecting device handling and clinical workflow
- Serve as device quality point of contact for assigned CMOs and off-the-shelf vendors
- Drive corrective action implementation, change control, and issue resolution
- Monitor supplier performance and escalate quality risks affecting clinical supply
- Support design control, risk management, engineering confidence testing, V&V, process development, DHF, and DMR activities as assigned
Requirements
What you’ll need- Bachelor’s Degree or equivalent in a scientific/engineering discipline (chemical, mechanical or biomedical engineering)
- 4+ years experience working in a Quality Assurance role for medical device/combination product
- Working knowledge of design/operation of medical device or drug combination product platforms
- Working knowledge of design controls, risk management, 21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR
- Hands-on experience with CAPA, deviations, change control, and root cause analysis tools (e.g., 5 Whys, fishbone, fault tree)
- Experience working with CMOs and external suppliers on issue resolution and corrective actions
- Exposure to design controls and risk management (DFMEA/PFMEA) in a development setting
- ASQ certification (CQE, CQA) or equivalent is an asset
Benefits
Comp & perks- Equal opportunity workplace
- Disability-related accommodation during the recruitment process
- Human rights-protected accommodation during the recruitment process