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Quality Engineer - Biomedical
Ref No.: 18-25680
Location: Fremont, California
Skill Type
Skill Type:Professional
Position Summary:
This candidate will work closely with cross functional teams to write, edit, review and finalize technical documents to support design transfer activities.  The individual will write or process, and implement all quality documents related to design transfer activities including procedure change orders and document change orders to reflect  approved changes. Identifies and drives improvement opportunities with areas through effective communication and ensures where quality issues arise that root cause is determined and the appropriate actions are agreed and implemented.

Key Responsibilities: 
  • Write and provide guidance in Design Transfer documentationTechnically strong to work independently with R&D and various scientists to transfer information from technical transfer memorandum from an early Design Control phase into brand new work instructions.
  • Designs a new layout for SOPs relating to Manufacturing production/process instructions, policies, and procedures
  • Creates part numbers and Bill of Materials into the Material Resource Planning (MRP) software
  • Lead cross functional documentation projects as required
  • Support Senior Scientists in corrective and preventive actions for technical issues to ensure timely and accurate documentation of root cause analysis
  • ¿Closely interacts and builds effective relationships with people across site to promote quality, consistency and compliance
Minimum Requirements/Qualifications:
  • BS/MS in a scientific discipline with 5-10 years diagnostic industry experience
  • Familiarity with SAP/ ERP system. 
  • Familiarity with Design Control
  • Must be computer literate and competent in PC based software such as Office 2010 Professional (Word, Excel, Access, and PowerPoint).Knowledge of ISO 13485, FDA QSRs and GMP
  • Proofreading and editing skills, and an aptitude for numbers and detail oriented work requiring a high degree of accuracy.
  • Proactive in suggesting improvements in workflow.
  • Must have excellent customer service and listening skills.
  • Able to sit, stand and/or use keyboard for long periods of time.Must have the skills to work as a strong contributor in a team effort.
  • Demonstrate good flexibility with changes to working environment and deliver high quality results in a high-pressured deadline oriented environment
  • Experience in preparing manufacturing documents including SOPs, specification sheets and worksheets.
  • Experience in IVD Manufacturing
  • Familiarity with Statistical Process Controls (SPC), Lean Quality Tools (FMEA, Pareto Charts, Fishbone Diagrams, Six Sigma)