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    Quality Engineering Consultant - Arizona, United States - Katalyst HealthCares & Life Sciences

    Katalyst HealthCares & Life Sciences
    Katalyst HealthCares & Life Sciences Arizona, United States

    1 day ago

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    Description
    Responsibilities:
  • Our client, a leading medical device manufacturer, is seeking a mid-level Quality Engineering Consultant to join their team on a contract basis. In this role, you will be responsible for providing expert-level quality engineering support to ensure the company's medical devices meet all regulatory requirements and quality standards.
  • Develop and implement quality control plans, including sampling strategies, inspection protocols, and testing procedures
  • Ensure compliance with relevant quality standards, regulations, and industry best practices (, ISO , FDA QSR, cGMP)
  • Collaborate with cross-functional teams, including manufacturing, design, and regulatory affairs, to identify and resolve quality-related issues
  • Perform root cause analysis and implement corrective and preventive actions to continuously improve the quality management system
  • Conduct risk assessments and failure mode and effects analyses (FMEAs) to proactively identify and mitigate potential quality risks
  • Review and analyze quality data, and provide recommendations for process improvements
  • Participate in design reviews, process validations, and other quality-related activities
  • Assist in the preparation of quality documentation, including control plans, process flow diagrams, and validation reports
  • Provide technical expertise and training to the client's quality engineering tea
    • Requirements:
  • Bachelor's degree in Engineering, Quality Assurance, or a related field.
  • years of experience in a quality engineering or quality assurance role within the medical device industry
  • Demonstrated expertise in quality management systems, risk management, and process validation..
  • In-depth knowledge of relevant quality standards, regulations, and industry best practices (, ISO , FDA QSR, cGMP).
  • Proficient in the use of quality management tools and software, such as SPC, FMEA, and validation documentation.
  • Strong problem-solving, critical thinking, and decision-making skills.
  • Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams.
  • Experience in leading quality improvement projects and driving continuous improvement initiatives.
  • Ability to work independently, adapt to changing priorities, and thrive in a fast-paced, dynamic environment.
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