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Quality Engineer III
Ref No.: 18-00028
Location: Fremont, California
Position Type:Contract
Start Date: 01/09/2018
DIRECT CLIENT REQUIREMENT
Job Title: Quality Engineer III
Location: Fremont, CA
Duration: 6 months

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 documentation
  • Technically 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)

Non-Negotiable Hiring Criteria:
Bachelor's degree or equivalent work experience

This position has not been approved for Relocation Assistance.
Company Information About client : Client Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies client and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support.

Key Responsibilities:
  • Write and provide guidance in Design Transfer documentation
  • Technically 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)
  • Non-Negotiable Hiring Criteria: Bachelor's degree or equivalent work experience
  • This position has not been approved for Relocation Assistance. Sincerely,