What are the responsibilities and job description for the Senior Manufacturing Quality Engineer – NPI position at Radiant Systems Inc?
We are hiring Senior Manufacturing Quality Engineer – NPI.
Please let me know if you are interested or anyone who might be interested.
Client: Major Medical Device Client
Position: Senior Manufacturing Quality Engineer – NPI
Duration: 7 months on W2
Location: Irvine, CA
Pay Rate: $60.00-$75.00/ Hr on W2
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Job Description
Summary
The regional NPI QE team, as part of the GQO Quality Assurance organization, is responsible for quality assurance activities, including, but not limited to, the following:
Key Accountabilities – NPI QE Standard Work
- Collaboration with R&D, AO & GQO throughout the NPI and overall product lifecycle
- Drive Process Risk Management activities
- Develop Effective Inspection processes
- Validation Quality Approver and, where certified, Validation Rep/Specialist
- Drive Process Excellence, pursuing validation over verification, where appropriate
- Own the NPI Purchasing Controls via PPAP and related efforts
- Design Transfer (in aggregate):
- Design and Process Transfer
- Project Transfer
General Responsibilities
- Foster collaborative internal/external professional relationships across Design Divisions, Advanced Operations & GQO functions associated with design transfer activities.
- Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.
- Mentor other groups on areas of expertise with particular attention to design and process transfer.
Risk Management
- Effective in risk management practices and tools, having high expertise in failure modes associated with production and production-related processes (PFMEA).
- Support the Risk Management File through Risk Management Principles.
- Responsible for the evaluation of process risks, risk mitigation, and ensuring appropriate production and process controls are identified, qualified, and implemented throughout the product manufacturing lifecycle.
- Ensure all Risk Management outputs comply with ISO 14971.
- Support the Design team to complete CQA/CTQ identification and provide inputs to dFMEA.
Inspection
- Implement lean inspection strategies and inspection plans through state-of-the-art inspection methods and technologies.
- Ensure inspections are repeatable, efficient, and scalable.
- Lead continuous improvements of inspection methods and sampling plans, with a focus on eliminating human error risks.
- Lead First Article Inspection (FAI) strategies, both internally and externally, and approve First Article Inspections.
- Optimize inspection costs through lean initiatives while maintaining product safety, integrity, and reliability.
Education
- Bachelor's degree in Engineering, Physical Sciences, or Statistics required.
- Master's degree in the same disciplines preferred.
- Minimum of 3 years of professional experience after graduation.
Must-Have Qualifications
- Collaboration with R&D, AO & GQO throughout the NPI and overall product lifecycle
- Ability to drive Process Risk Management activities
- Experience developing effective inspection processes
Nice-to-Have Qualifications
- Validation Quality Approver and, where certified, Validation Representative/Specialist
- Experience driving Process Excellence, pursuing validation over verification where appropriate
- Experience owning NPI Purchasing Controls through PPAP and related efforts
Regards
Vishnu Das Natesan
dvishnu@radiants.com
Salary : $60 - $75