Quality Assurance Specialist

1 day ago


Phoenix, Arizona, United States Katalyst HealthCares & Life Sciences Full time
Quality Engineering Consultant

Katalyst HealthCares & Life Sciences is seeking a seasoned Quality Engineering Consultant to provide expert-level quality engineering support to ensure our medical devices meet all regulatory requirements and quality standards.

Key Responsibilities:
  • 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 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 quality engineering team.
Requirements:
  • Bachelor's degree in Engineering, Quality Assurance, or a related field.
  • Minimum 5 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.
  • Proficient in the use of quality management tools and software.
  • Strong problem-solving, critical thinking, and decision-making skills.
  • Excellent communication and interpersonal skills.
  • Experience in leading quality improvement projects and driving continuous improvement initiatives.


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