Quality Engineer
Core
Establishing and maintaining a quality system to ensure full compliance with regulatory requirements (FDA, EU) and internal standards for a biopharmaceutical company.
Role type
Quality Engineer
Builds
Quality systems and compliance frameworks
Domain
Biopharmaceutical / Medical Device
Deliverable
client delivery
Required skills
Quality system documentation, regulatory compliance assessment, performance metrics generation, internal audit support, CAPA management, inspection readiness, training delivery, data integrity management
Preferred skills
Science qualification, hands-on relationship building, sound judgment, self-direction, prioritization, presentation skills
Technologies
None stated
Responsibilities
Coordinate the quality system to ensure full compliance by all personnel; Measure and report on quality system performance at management reviews; Act as the point of contact for quality system and compliance activities including training, metrics, and audits; Support inspection readiness and manage CAPA responses; Adhere to EHS standards.
Seniority
Mid-level, hands-on IC