Position: Senior Quality Engineer, Req : 11468-1
Location: Irvine, CA (100% Onsite, Typical 8-hour per day, not expecting overtime, 5-day per week onsite required)
Duration: 18+ Months Contract
Job Description:
The Quality Engineer will collaborate with a cross-functional design team to develop novel cardiovascular devices/therapy, providing quality leadership and vision throughout the initial product development cycle up to commercialization, while ensuring compliance with applicable internal and external requirements. In this position, the engineer will work closely with R&D to define strategy, as well as refine and finalize the design per the NPD process. In addition, the engineer will work with the Operations team to help facilitate the successful transfer/launching of robust products. This position provides an opportunity to work in a fast-paced and dynamic environment where taking initiative and collaborating cross-functionally are critical for success.
More on this position:
Microsoft Office, Minitab
NPD experience as Quality/Design Assurance in Early Human Use, ISO 13485, ISO 14971
Experience in early medical device development as Design Assurance/Quality Engineer, results-driven, flexible and critical thinking
Must-haves? Design control in medical devices, NPD Quality Assurance, Risk Management
What are nice-to-have skills? Design Six Sigma, ISO 14971, Early Human Use
Is there anything that would automatically disqualify a candidate? No quality engineering experience, no medical device experience
Education and Experience:
- Bachelor's Degree or equivalent in Engineering with 4 years of related industry experience OR Master's Degree in Engineering with 3 years of related industry experience