PS
PCI Pharma ServicesQuality Engineer – Sustaining Engineering
Quality Engineer responsible for planning and implementing validation strategies at PCI Pharma Services. Collaborating with various teams to ensure compliance and product quality.
About the role
- Led advanced prototyping, testing, and research initiatives
- Solved intricate design challenges independently
- Designed and developed software systems
- Authored and reviewed comprehensive project documentation
- Applied deep understanding of clinical workflows and customer needs
Requirements
- Bachelor’s degree in a science or engineering
- Minimum of 6+ years of experience working in a highly regulated industry
- Experience with software lifecycle processes (Agile SAFe/Waterfall)
- Experience with software Failure Modes Effect Analysis (sFMEA)
- Experience with regulatory agencies (FDA, MoH, TUV) and medical device regulations (820, IEC 62304/82304, 60601)
Benefits
- bonus eligible
- health insurance
- flexible work arrangements
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