Quality Engineer

Job Description

TITLE: Quality Engineer
DEPARTMENT: Quality Assurance
REPORTS TO: QA Manager

Position Summary

Under minimum supervision, establish and maintain appropriate Quality systems consistent with ISO 13485 and cGMP in a start-up environment.  The resultant quality system successfully addresses the needs of Medical instrument design and manufacturing and diagnostic consumable design and manufacturing for 510(K) Class II devices.

Principal Responsibilities

Responsibilities may include but will not be limited to the following as assigned:

  • Evaluate, implement, and maintain quality assurance programs and systems including Nonconforming Materials, Deviations, and Corrective and Preventive Actions to ensure product quality.
  • Work collaboratively with quality and manufacturing to create and/or modify methods and procedures to ensure that appropriate processes and /or products are developed, tests are conducted and that products, materials and manufacturing equipment meet required standards.
  • Perform statistical analysis to analyze trends, work with engineering and manufacturing to investigate trends, and conduct root cause analysis for nonconforming processes and products.
  • Represent the quality systems in communications with vendors, customers, and auditors.
  • Maintain compliance with all company policies, quality systems, and procedures.
  • Perform other duties as assigned by supervisor.

Essential Requirements

  • 5 – 7 years related quality experience in an ISO 13485 and cGMP in an FDA regulated environment.
  • Bachelor’s degree in chemistry, biochemistry, microbiology, engineering, or a related discipline.
  • Experience as a Quality Engineer in the medical device, diagnostics, pharmaceutical, or biologics field.
  • Familiar with design review processes, and capable to perform risk analysis and develop risk mitigation plans.
  • Previous experience with the investigation of quality events (deviations, non-conformances) and the management of CAPA systems to demonstrate effective resolution.
  • Understanding of validation principles and practices, with past experience in the execution, review, and approval of validation activities.

To apply please e-mail Cover Letter and CV to careers@genalyte.com.

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