Staff QA Engineer
Core
Ensure product quality and regulatory compliance across operations at the intersection of quality assurance, regulatory compliance, and continuous improvement.
Role type
Staff QA Engineer (Regulated Industries)
Builds
Life-changing scientific solutions for customers in health, environment, and food safety sectors.
Domain
Life Sciences / Pharmaceutical / Medical Device / Biotech
Required skills
GMP regulations, ISO standards (9001, 13485), regulatory requirements (FDA, EMA), internal/external audits, quality systems (CAPA, change control, document control, risk management), validation activities (IQ/OQ/PQ, process validation, computer system validation), project management, cross-functional team leadership, problem-solving, analytical skills, quality management software (TrackWise, SAP), data integrity, technical documentation review.
Preferred skills
ASQ CQE, CQA, Engineering/Life Sciences/Chemistry/Biology degree.
Technologies
TrackWise, SAP
Responsibilities
Conduct audits (internal, external, regulatory, client), manage validation activities, support quality professionals, review and approve technical documentation, protocols, and reports, collaborate on quality initiatives.
Seniority
Staff, hands-on IC with leadership
