Sr R&D Quality Assurance Engineer F/M
Core
Ensuring regulatory compliance and product quality for medical devices and combination products throughout the R&D lifecycle.
Role type
Senior R&D Quality Assurance Engineer (Medical Device & Combination Products)
Builds
Regulatory-compliant medical devices and combination products for patient use
Domain
Pharmaceutical R&D / Medical Devices / Regulatory Compliance
Deliverable
client delivery
Required skills
Design control process implementation, risk management, regulatory requirement interpretation, corrective and preventive action (CAPA) management, quality document authoring, clinical product control, non-compliance investigation
Preferred skills
Biomedical/mechanical/chemical/pharmaceutical engineering background, aseptic techniques expertise, ISO13485 and FDA regulations knowledge, instructor-led training facilitation
Technologies
ISO13485, FDA regulations, 21 CFR Part 820
Responsibilities
Support R&D teams in implementing the design control process, participate in design reviews and analysis of needs and specifications, ensure product compliance through the risk management process, coordinate quality actions for R&D clinical product control, deploy quality culture as a project representative
Seniority
Senior, hands-on IC