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Quality Engineer III

Dawar Consulting, Inc.
Santa Clara, CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

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.
       

Best Regards,
        Dawar Consulting Inc.

Dawar Consulting, Inc.

Address

Santa Clara, CA
USA

Industry

Manufacturing

View all jobs at Dawar Consulting, Inc.