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Quality Engineer

Location: Fremont, CA, United States
Job # 11398370
Date Posted: 09-21-2018
Quality Engineer- Fremont, CA 94538
Pay Rate: $70-$85/hr.
Schedule: 40 hours a week
Long term assignment

Start Date: ASAP

The Quality Engineer is a diverse and challenging role in our start up environment. You will be responsible for the quality assurance of product design and supplier controls / performance.  Because of your prior experience you understand and will be able to implement the relevant requirements of the Quality System Regulation (21 CFR 820) and ISO 13485. In addition, you will also initiate and facilitates improvements to the quality system. 
You will be hands on with new product development and providing technical support and leadership of quality deliverables.  As a quality engineering professional you know how important it is to be involved during all the product development phases to support creation of design controls as well as process qualification/validation activities.
Are your ready for the opportunity to make a meaningful difference in the design and manufacture of a world class medical device?
  • Experience with medical instrumentation and disposables
  • Practical knowledge of use of quality and statistical tools
  • Deep understanding of both QSR and ISO
  • Participate in Risk Analysis (Design Process) meetings and internal quality audits
  • Work with suppliers to complete corrective and preventive actions, product/process improvements and procedure development and training.
Qualifications
  • Four year degree in science or a technical field with at least twelve years of related experience
  • Experience in the creation of procedures, protocols, test reports, and work instructions
  • A plus would be experience with robotics/software, supplier quality 
  • Certified Quality Engineer and ISO 13485 Lead Auditor would also be a nice to have
Please send your resume in a Word or PDF format for immediate consideration.g
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