Description
General purpose of job- Serve as primary QA representative for new product development activity
- Participate in routine, day-to-day operation of the quality system (as necessary to support product development and general operations activities)
- Conduct independent testing to assure product conformance to requirements/specifications
- Contribute to creation and routine maintenance of the quality system
Core product-related duties & responsibilities
- Participate in development and maintenance of product design documentation (e.g., customer needs, product requirements, hardware/material/software requirements/specifications, DMR content)
- Principal QA contact for design V&V activities (including planning, plan review/approval, protocol development, protocol review/approval, protocol execution, reporting and report review/approval)
- Principal QA responsibility for process validation activities (including planning, plan review/approval, protocol development, protocol review/approval, protocol execution, reporting and report review/approval)
- Participate in product risk management activity
- Participate in product design review process
- Participate in product change review/approval process
- Participate in supplier selection/audit/approval activities
- Participate in planning and execution of supplier product qualification activities
- Participate in planning of incoming acceptance activities (including establishing sampling plans)
- Participate in other design transfer activities (as necessary)
- Review of customer test reports
Education
- Bachelor's degree in a relative technical field (e.g., biology, chemistry, biomedical sciences)
- Alternative: Associate's degree in technical field with minimum of 10 years relevant experience or high school diploma with minimum of 15 years relevant experience
Preferred experience
Minimum of 5 years of experience in the following types of commercial environments:
- Development and/or manufacturing of bio./chem. based diagnostic medical products (e.g., IVDDs)
- Clinical laboratory testing service (e.g., CLIA) operations
- Minimum of 5 years of hands-on experience with the following types of equipment/analytical methods:
- ELISA (pipette, plate washer, plate reader)
- Western Blot
- SDS-PAGE
- Spectrophotometer
- Experience with implementation and/or maintenance of quality systems conforming to GMP/QSR, ISO 13485 and CLIA requirements
To find out more about Real please visit www.realstaffing.com