Sr Quality Engineer

2 weeks ago

St Louis, Missouri, United States Katalyst Healthcares & Life Sciences Full time

Responsibilities:

  • Develop, implement, and maintain Quality Management Systems (QMS) in compliance with FDA, EMA, ICH guidelines, and other regulatory requirements.
  • Ensure all processes and products comply with applicable regulatory standards, including cGMP.
  • Lead continuous improvement initiatives to enhance product quality, efficiency, and compliance.
  • Oversee validation activities, including equipment, process, and cleaning validations, ensuring compliance with industry standards.
  • Conduct thorough investigations into quality issues, perform root cause analysis, and implement corrective and preventive actions (CAPA).
  • Plan and conduct internal audits, support external regulatory inspections, and manage responses to audit findings.
  • Evaluate and qualify suppliers, conduct supplier audits, and ensure supplier compliance with quality standards.
  • Maintain accurate and comprehensive quality documentation, including SOPs, batch records, and validation protocols.
  • Mentor and develop junior quality engineers and quality assurance staff, fostering a culture of continuous improvement and quality excellence.
  • Perform risk assessments and implement risk mitigation strategies related to product quality and regulatory compliance.
  • Work closely with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality considerations are integrated into all phases of product development and production.

Requirements:

  • 7-10 years of experience in Quality Assurance within a FDA/GMP environment (pharmaceutical or medical device industry required).
  • Bachelor's degree in a scientific field (Life Sciences, Biotechnology, or equivalent) is required.
  • Proficiency in quality management software, statistical analysis tools, and methodologies such as Six Sigma, Lean.
  • Strong understanding of Quality Management Systems.
  • Previous experience with hosting client audits and/or regulatory inspections.
  • Excellent communication skills.

Additional Skills & Qualifications:

  • Certified Quality Engineer (CQE) or Certified Quality Auditor certification preferred.
  • Experience with electronic Quality and Training Management Systems.

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