Engineer I, QA - (m/f/d) Part-time 50% (19.25 hours/week)
Core
Maintaining and continuously improving the Quality Management System (QMS) per ISO 9001:2015 standards.
Role type
Quality Management Engineer
Builds
Quality management processes and documentation for immunological detection systems
Domain
Life Sciences / Biotechnology / Quality Assurance
Deliverable
dashboards & analysis
Required skills
ISO 9001:2015 knowledge, CAPA management, risk analysis, FMEA, change management, validation support, document control
Preferred skills
Natural sciences background, regulated industry experience
Technologies
MS Office
Responsibilities
Monitor QMS, create and revise QM documents, support internal/external audits, handle deviations and CAPAs, participate in risk analysis and FMEA, support validation projects, assist in training
Seniority
Entry-level to Mid-level, hands-on IC
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