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Quality Engineer

Location: San Jose, CA, United States
Job # 11375915
Date Posted: 09-14-2018
Quality Engineer
San Jose, CA 95131
Salary Rate: $100,000/yr
Direct Hire Role
About Company and Opportunity:
Our client is a leading global supplier of solutions for the biopharma, forensic and diagnostic industries. The company is a leader in the development, production and distribution of advanced automation and detection solutions for the world‘s leading life science laboratories. Ambitious to contribute to the quality of life of humankind by enabling our customers to make the world and our community a healthier and safer place.

This is a permanent opportunity to grow with a fast paced biotech company including benefits, PTO, and retirement plans. You will be a major contributor to our organization and essential to the growing need in our Quality department.
Essential Job Duties:
We are seeking the right individual to partner with local and global Engineering, customers, and suppliers to ensure effective product development. You will apply moderate to complex engineering principles to develop methods and procedures to continuously improve our products and processes, with latitude for independent action and decision.
  • Support Company goals in continued QSR and ISO compliance, training and customer satisfaction.
  • Participate on R&D project teams for development of new products or changes to existing product.
  • Responsible for incoming inspection criteria for new components, creation and maintenance of supplier capability reviews, participation and input to design reviews and statistical analysis as input to V&V activities.
  • Define supplier quality specifications, sampling plans and supplier qualification.
  • Perform root cause analysis and implementation of corrective actions for product and process related activities, e.g. CAPA, complaints, SCARs.
  • Provide Quality participation and oversight in the investigation process.
  • Provide input to Risk Management Activities including FMEA and corrective actions.
  • Provide guidance and participate in production process validations, e.g. planning, approval process, V&V, creation of inspection plans, supplier process controls, L&P process controls and implementation of statistical analysis.
  • Develop and drive continuous improvement projects for the quality department. 
Essential Requirements / Training:
  • BS in ME/EE preferred.
  • Minimum 5 years of experience in a regulated industry e.g. medical device, automotive, etc.; preferably in a product development and manufacturing environment
  • ‚ÄčUnderstands and applies principles, concepts, practices and industry standards, specifically FDA QSR/ISO 13485.
  • Excellent written and verbal communication skills, including good facilitation skills, and engaging presentation style. 
  • Proficient in Microsoft Office. Excellent at MS Excel.
  • SAP or other ERP proficiency desirable.
  • Capable of reading and interpreting engineering drawings and specifications
  • Must be able to communicate effectively at varying technical levels with an international audience.
  • Demonstrated mechanical/electrical problem solving skills.
  • Demonstrated strong analytical problem solving (CAPA) skills.
If qualified, please apply with your resume in PDF or Word format. #DI
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