Quality Engineer

Santa Clara  ‐ Onsite
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Keywords

Description

Provide QA technical and compliance expertise as part of development teams in establishing and assuring product quality objectives. Assure compliance to applicable regulations. Perform quality activities such as risk management, verification and validation, audits support, procedure development, product release, documentation review and define changes to controlled documents.
Core Job Responsibilities
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Plans, executes, reports and follows-up on quality system audits (supplier and internal)
Actively participates on cross-functional team projects in a structured business environment in accordance with internal procedures and external regulations
Monitors compliance with company policies, procedures and applicable regulatory requirements
Tracks and reports progress across projects and departmental commitments by reviewing schedules and due dates, identifying risks, and assisting teams with contingency plans
Qualifications
Bachelor's Degree in Engineering, Chemistry, Biology or related science/technical field or an equivalent combination of education and work experience.
Auditor certification from an industry recognized organization desired
Knowledge of Design Control and Risk Management
Knowledge of Verification and Validation activity

3-5 years experience in an FDA regulated industry (Biotech, Pharma or Medical Device manufacturing)
Start date
07/2014
From
Real Staffing
Published at
09.07.2014
Project ID:
738739
Contract type
Freelance
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