Senior Quality Assurance Investigator

2 days ago


East Hartford, Connecticut, United States Apex Systems Full time
Senior Quality Assurance Analyst - Investigations

Apex Systems is seeking an experienced Senior Quality Assurance Analyst to join our team. This role requires a strong background in investigations and customer complaints, with a focus on quality management and process improvement.

Key Responsibilities:
  • Conduct investigations into quality issues and customer complaints, identifying root causes and proposing corrective actions.
  • Develop and implement process improvements, working closely with cross-functional teams to drive continuous quality enhancement.
  • Prepare detailed reports and presentations on investigation outcomes, providing actionable insights to stakeholders.
  • Mentor junior analysts and provide guidance on investigation techniques, ensuring knowledge transfer and skill development.
  • Collaborate with regulatory bodies and auditors to ensure compliance with industry standards and regulations.
Requirements:
  • Bachelor's Degree in Chemistry, Engineering, Microbiology, or related field, or equivalent experience.
  • 5+ years of experience in production/manufacturing environments, handling customer complaints and internal process investigations.
  • Proficiency in quality management software and ERP systems, as well as MS Word and Excel.
  • Experience in regulatory compliance and managing audits, with a proven track record of conducting investigations and implementing CAPAs.
  • Strong analytical and project management skills, with the ability to analyze data trends and identify opportunities for process improvement.
Preferred Qualifications:
  • Current experience in a pharmaceutical or medical device production/manufacturing environment.
  • Certification in quality management, such as Six Sigma or Certified Quality Engineer.
  • Proficiency in root cause analysis tools and quality management software.

Apex Systems is an equal opportunity employer, committed to diversity and inclusion. We welcome applications from qualified candidates who share our values and are passionate about delivering exceptional quality and service.



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