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
- Manage the development and implementation of methods and procedures for process control, process validation, process improvement, testing, and inspection.
- Design experiments to understand sources of variation affecting products and processes.
- Direct and collaborate with supplier representatives on quality problems and ensure corrective action implementation (CAPA, SCAR).
- Work with Regulatory Groups and Suppliers to produce 510K submissions, letters to file, etc.
- Perform quality reviews of design documentation for compliance with stated requirements.
Requirements
- Typically requires a Bachelor’s degree in Engineering, Science, Math or other related technical field.
- At least 2 years of experience in the Quality or Engineering.
- Experience using MS Office Suite products (Word, Excel, PowerPoint, Outlook).
- Intermediate Skill Level in Microsoft Excel (conditional formatting, tables, formulas, charting).
- Working knowledge of government and industry quality assurance codes and standards (e.g. 21 CFR 820, ISO13485).
Benefits
- Health insurance
- Life and disability insurance
- 401(k) contributions
- Paid time off
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