Staff QA Engineer
Core
Ensuring product quality and regulatory compliance across operations at the intersection of quality assurance, regulatory compliance, and continuous improvement.
Role type
Staff QA Engineer
Builds
Life-changing scientific solutions for customers in health, environment, and food safety
Domain
Life Sciences / Pharmaceutical / Medical Device / Biotech
Deliverable
client delivery
Required skills
GMP regulations, ISO standards (9001, 13485), regulatory requirements (FDA, EMA), internal and external audits, quality systems (CAPA, change control, document control, risk management), quality tools (FMEA, root cause analysis, statistical analysis), validation activities (IQ/OQ/PQ, process validation, computer system validation), project management, cross-functional team leadership, problem-solving, analytical skills, quality management software systems (TrackWise, SAP), data integrity requirements, technical documentation review
Preferred skills
ASQ CQE, CQA, relevant industry certifications
Technologies
TrackWise, SAP
Responsibilities
Conducting internal and external audits including regulatory inspections and client audits, managing validation activities, reviewing and approving technical documentation, protocols, and reports, supporting quality professionals, advancing quality initiatives
Seniority
Staff, hands-on IC with leadership
