Role: QA Automation Manager
Location: Rochester, NY
Experience: Minimum 10+ Years
We are looking for an QA Automation Manager to lead quality engineering initiatives within a highly regulated healthcare and medical device environment. The ideal candidate will have strong leadership skills, expertise in Quality Management Systems, regulatory compliance, and quality process improvement while driving operational excellence across cross-functional teams.
Responsibilities
Lead, mentor, and develop a team of quality professionals to achieve organizational and business objectives.
Establish team priorities, allocate resources, and ensure timely delivery of quality initiatives.
Provide leadership in quality systems, regulatory compliance, and operational excellence.
Partner with Manufacturing, Engineering, Research and Development, Regulatory Affairs, Supply Chain, and cross-functional teams to ensure quality throughout the product lifecycle.
Ensure compliance with Quality Management System requirements, including ISO 13485, FDA 21 CFR Part 820, and IVDR regulations.
Support regulatory inspections, internal audits, and external audits while maintaining inspection readiness.
Review and approve manufacturing deviations, corrective actions, rework instructions, and quality-related documentation.
Drive continuous improvement initiatives through process optimization, standardization, and quality system enhancements.
Analyze quality metrics, identify risks, perform root cause analysis, and implement sustainable corrective actions.
Provide technical guidance and support for production quality issues and operational excellence.
Required Skills
Minimum 9+ years of progressive experience in Quality, Compliance, or Quality Engineering.
Minimum 4+ years of experience leading technical or quality teams.
Strong understanding of Quality Management Systems and regulatory requirements.
Hands-on experience with ISO 13485, FDA 21 CFR Part 820, and IVDR.
Experience supporting regulatory inspections, audits, and compliance initiatives.
Strong knowledge of manufacturing quality processes, CAPA, deviations, and root cause analysis.
Experience working in Medical Device, Life Sciences, Healthcare, or Biopharmaceutical industries.
Strong analytical, leadership, communication, and stakeholder management skills.
Preferred Skills
Experience leading quality transformation and continuous improvement initiatives.
Knowledge of risk management and operational excellence methodologies.
Experience working in cross-functional environments supporting product development and manufacturing.
Education
Bachelor's degree in Engineering, Life Sciences, or a related technical discipline.
