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CompassX GroupQuality Assurance Engineer – 6 Month Contract
QA Engineer ensuring reliability and performance of Android - based POS systems at CompassX. Collaborating with teams to execute testing and support operations in a hybrid role.
About the role
- Plan, develop, implement and monitor the equipment and process validation strategy for PCI’s Advanced Drug Delivery business
- Partner with internal team members to ensure successful design/tech transfer with NPI by supporting or driving validation processes with appropriate risk management leadership
- Responsible for supporting all phases process qualification, ensuring product production according to established control plan, design and product specifications
- Drive continual improvement by implementing validation strategies, conducting tests, and analyzing data to confirm compliance and functionality
- Interact and collaborate with internal team members, customers, suppliers, and contract service providers as needed
- Develop and implement product and process workflows to ensure best engineering practices
Requirements
- College or Trade Degree required (engineering degree or related scientific degree preferred)
- 3+ years of experience in an FDA regulated industry with strong preference to medical device or combination products
- Proficiency with personal computers, business software (e.g., MS Office) and technical software (ERP and eQMS systems)
- Ability to create, use and interpret scientific tables, charts, and graphs
- Lean Six Sigma Certification, ASQ Certified Quality Engineer (CQE), or similar certifications are highly desirable
- Excellent organizational, time management and multi-tasking skills to meet commitments and deadlines
- Prior experience in technical writing and utilizing root cause analysis tools
- Critical thinking skills along with a strong collaborative approach
- Technical knowledge and experience around Test Method validation, Medical Devices, and Sterilization processes is preferred
Benefits
- paid time off
- health insurance coverage (including dental and vision)
- a flexible spending account
- 401(k) plan
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