Description
Hi,
This is Rohini with SSI, We have an immediate opening for QA Engineer Consultant II with our Direct client. If you are interested please reach me with your Updated Resume
Title: QA Engineer Consultant II
Duration: 12months + (will extend after that)
Location: North Maple Grove MN 55311
Description:
What You Will Do:
- You will be supporting R&D integration efforts, including the remediation of Risk Files of Legacy SPNC Products. Activities include creating of Risk Management Matrix, converting from Legacy FMEA template's to Philips FMEA templates, assess risks to new risk classifications, identify gaps is previous verification and validation activities and then address gaps as needed.
What Success Looks Like:
- Create Risk Management Matrix for Legacy products, using the PHA's, DFMEA, UFMEA and complaint history.
- Convert Legacy UFMEA, DFMEA and PFMEA into new templates, developing language that is more patient focused.
- Reassess Risk Classifications using new templates and identify where Risk Classifications have increased.
- Identify gaps in verification, validation or component qualification testing occur due to a change in Risk Classification and develop and execute a plan to close gap.
- Collaborate with Development Engineering and Design Assurance Engineering stakeholders to develop strategies and review work.
- Tracks and reports progress and will communicate any identified risks or delays to projects.
Desired Experience:
- B.S. of Mechanical, Chemical, Industrial, Materials or Biomedical Engineering or similar field
- 5+ years of experience working in verification and validation of Medical Devices as a Quality Engineer or Development Engineer.
- Must have experience in applying Risk Management using a life cycle approach.
- Working knowledge of 21 CFR 820, ISO 13485, and ISO 14971.
- Experience creating FMEA's, writing test protocols and reports and developing engineering justifications.
- Experience with MS Word and MS Excel.
- Ability to travel up to 10%.