Quality Engineer III

Our client, (a Pharmaceuticals and Diagnostics company), is seeking an experienced Quality Engineer.

Job Title: Quality Engineer

Duration: Long Term Contract, Onsite

Location: Santa Clara, CA

Hourly Rate: $52/hr on W2 with Benefits (incl. Medical, 401k, Sick leave)

ROLES & RESPONSIBILITIES:

• Provide Design Control guidance to product development under direction from Life Cycle Teams (LCT)
  
• Act as the single point representative for all Quality Management System activities for Project Teams.
  
• Review and approve documentation consistent with design control regulations and guidance our clients Diagnostic Divisional Standards and business area/unit specific processes and procedures
  
• Documentation includes, but is not limited to, design control-related documents such as design development plans, risk management plans/reports, customer requirements, product requirements, technical performance verification protocols/reports, clinical study plans/reports, design transfer documents, labeling, and milestone documentation
  
• Communicate critical product quality or compliance-related issues to Quality Management to ensure alignment with Quality policy and objectives
  
• Participate in difficult discussions, challenge the status quo, and identify mutually beneficial compliant solutions with cross-functional colleagues at the Project Team level 
  
• Work closely and partner with DQA colleagues within and across sites to ensure consistent application of design control-related processes
  
• Author Quality Reports 
  
• Advise and support Project Teams during the planning of milestones to complete required deliverables
  
• Assist management in assessment of whether the project has met requirements to pass milestone.
  
• Provide feedback on new or revised SOPs associated with design control activities/compliance 
  
• May be the key contributor/coordinator for Quality feedback on SOP revisions working closely with the respective SOP owner and DQA leadership
  
• Support internal and external audits/inspections 
  
• May Proxy for QFL as requested for LCT 
  
• Activities may include non-conformance review and approval, and document change review and approval within Trackwise. 
  
• Activities may include equipment installation qualification review and approval.
  

      EXPERIENCE/SKILLS :            

• A minimum of 8+ years of experience under established quality regulations
  
• Intermediate knowledge of medical device or pharma processes
  
• knowledge of in-vitro diagnostic products including nucleic acid based products is preferred
  
• Strong track record of successful participation on cross-functional teams
  
• Working knowledge of QSR/cGMP, ISO and Design Controls
  

Please respond with your updated resume and contact information to hr@dawarconsulting.com.