Quality Engineer III

San Francisco  ‐ Onsite
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Keywords

Description

The Client:

The Client is the world leader in providing early stage diagnosis and management of cardiac arrhythmia information. They are aiming to simplify long-term monitoring solution to improve patient outcomes and reduce costs.

The Role:

The Quality Engineer III will provide technical engineering support of product life cycle, from concept through commercialization and post-market evaluation. Will also help establish and maintain Quality System compliance to all applicable regulatory requirements.

Responsibilities:
  • Serves as a Quality Assurance representative on one or more project teams engaged in new product development, quality processes improvements, business system implementations or other special projects
  • Knowledge in Quality Systems to execute overall project assignments
  • Apply statistical tools to analyze data and identify root cause and problem resolution
  • Identify and routinely use the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
  • Review and approve product documentation, drawings, process and design verification/validation
  • Serve as technical resource for assessing validation requirements, solving test related problems, and developing preventive strategies
  • Perform and lead risk assessment exercises in support of validation activities
  • Plans, develops, implements, and maintains the document change control system.
  • Consider the application of privacy, security, environmental, health and safety standards.
  • Assist and participate in internal and external audits, including supplier audits.
  • Produce technical reports to support product changes or quality assurance investigations.

Required Qualifications:
  • B.S in Engineering or relevant science.
  • 7-10 years of experience in Quality Assurance
  • 21 CFR 820, MDD/CMDR, ISO13485, ISO 14971, IEC 60601, HIPAA
  • Exceptional problem-solving skills.
  • Exceptional organizational skills.
  • 20% Travel
  • Experience with ERP/MRP systems
Start date
08/2014
From
Real Staffing
Published at
10.08.2014
Project ID:
756138
Contract type
Permanent
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