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Quality Engineer

San Lorenzo, PR


The Quality Engineer will utilize Quality Engineering tools and practices for the effective and efficient development, transfer and maintenance of products/processes throughout the product life-cycle. The incumbent will also utilize Quality Engineering principles and problem solving skills to improve and maintain products/processes that are aligned with the overall Quality and Business vision. He/she will utilize appropriate risk management to prevent unanticipated failure modes and improve capability of processes. Ensure compliance with company policies and procedures such as Design Control, Process Validation, Test Method Validation, and Sampling Plan Development and Review. Generates quality indicators and supports non-conformance investigation and corrective action implementation at the business unit level and/or Plant level. Candidate must possess Regulatory Experience in the Pharmaceutical, Biotechnology or Medical Devices industry. 

  • Bachelor's in Science or Engineering
  • Minimum of Two (3) years of related experience in a regulated industry is required; Medical Device experience is preferred
  • ASQ Certified Quality Engineer preferred
  • Black/Green belt Six Sigma certification preferred
  • Must also have track record of appropriate training (internal / external) on statistical technique competencies
  • Quality System Regulations and ISO 9000 knowledge
  • Bilingual (English & Spanish)
Integrated Technology and Compliance Services is an Equal Opportunity Employer

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