Job Title: QA Automation Manager

Introduction:

The QA Automation Manager will be responsible for overseeing and managing the quality assurance processes within the organization. This individual will lead a team of quality professionals to ensure compliance with ISO 13485, FDA regulations, and other quality standards. The QA Automation Manager will also be responsible for implementing automated testing processes, collaborating with cross-functional teams, and driving continuous improvement initiatives.

Responsibilities:

• Lead a team of quality professionals to ensure compliance with ISO 13485, FDA regulations, and other quality standards
• Implement automated testing processes to improve efficiency and accuracy of quality assurance activities
• Collaborate with cross-functional teams to ensure quality standards are met throughout the organization
• Drive continuous improvement initiatives to enhance quality assurance processes and procedures
• Conduct audits, inspections, and root cause analysis to identify and address quality issues
• Provide leadership and guidance to the quality team to ensure goals and objectives are met

Requirements:

• 7+ years of Quality/Compliance experience in Medical Device, IVD, or Biopharma
• 3+ years of team leadership experience
• Strong knowledge of ISO 13485, FDA 21 CFR 820, IVDR, and Quality Management Systems (QMS)
• Experience with CAPA, manufacturing quality, deviations, batch release, audits, and inspection readiness
• Expertise in regulatory compliance, root cause analysis, continuous improvement, and cross-functional collaboration
• Bachelor''''s degree in Life Sciences, Engineering, or related field

Preferred:

• Lean Six Sigma, PMP, or equivalent certification
• Experience with global QMS, digital quality tools, and Health Authority/Notified Body inspections
• Strong technical manager with extensive hands-on experience in Test Automation and solid expertise in Quality Assurance and Quality Engineering practices