Associate Director – Quality

Associate Director – Quality

Requirements

• BS Required (in Science, Engineering, or equivalent)
• 10+ years of total experience in Quality with a 7 years supporting IVD medical device design and development
• Advanced working knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971 and related medical device regulations and standards
• Experience leading inspection readiness activities and coordinating regulatory agency inspections
• Experience with conducting audits as a lead auditor
• Demonstrated strategic and tactical leadership building a high-performance results driven team
• Strong interpersonal and communication skills, including written and verbal communication, and presentation skills

Responsibilities

• Develop, implement, maintain, and continuously improve policies and procedures for DELFI’s QMS to ensure compliance with all applicable requirements including FDA 21 CFR Part 820, ISO 13485, CLIA, CAP, NYSDOH, and GCP
• Lead and own a number of key Quality System Elements for DELFI’s QMS including but not limited to the following: Design Quality, Internal and External audits, Nonconformance Handling, Corrective Action Preventive Action (CAPA), Complaint Handling, Management Review, Supplier Quality, Risk Management, Change Management, Document Control, Training, and Record Management from implementation to maintenance
• Oversee day to day Quality work for the organization and provide guidance to ensure compliance and effective processes are maintained
• Support cross-functional teams responsible for implementation of new products, process improvements, and troubleshooting activities
• Provide support and assistance to cross functional teams to drive inspection readiness activities and support regulatory authority inspections
• Lead organizational compliance to all applicable regulatory and company procedures by providing continuous guidance, training, and education

Preferred Qualifications

• Previous experience supporting LDT laboratories and proficient with CAP/CLIA standards and regulations
• Ability to influence, build, and foster relationships horizontally and vertically across the organization
• Certified Lead Auditor
• Ability to address and resolve a variety of complex issues diplomatically
• Molecular diagnostics background