Position Overview

The Manager, Post-Market Quality - IVD is a unique opportunity to establish and maintain the quality processes and programs for IVD products in the areas of Complaints Management, Adverse Event Reporting, Recalls, CAPA and Post-Market Surveillance. The successful candidate will be a coach to the organization for all post-market activities and will help to improve product quality and maintain compliance to international regulations.

Responsibilities

• Provide Quality leadership for Complaints Management, Post Market Compliance, CAPA Management, Management Review, Performance and Compliance Metrics Reporting, and Post Market Surveillance.
• Define and implement the processes required for post market compliance for on market product distributed around the world in accordance to policy and procedures, including non-conformances, risk evaluations, investigations, and product dispositions.
• Implement and oversee a global complaints management process, including complaints registration, evaluation, investigation, and vigilance reporting, and periodic summary reports to regulatory agencies around the world.
• Collaborate with R&D, Manufacturing, and service teams and external stakeholders to help investigate and resolve quality issues
• Manage CAPAs, including potential/nonconformances, risk impact assessments, investigations, planning and executing actions, and verifying effectiveness.
• Help conduct management reviews, including site and executive reviews.
• Maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• Responsible for all activities related to post market surveillance, including periodic reporting for medical devices and in vitro diagnostic devices and collaborating with stakeholders to identify and gather essential inputs to the process and reports.
• Participates in internal and external audits by regulatory agencies
• Identify opportunities to proactively assure compliance to all applicable internal, domestic and international quality regulations, US 21 CFR 820 (QSR), ISO 13485, etc.
• Identify Quality Initiatives and lead cross-functional teams to complete them.
• Provide coaching and development support to team members.

Required Skills and Experience

• BS degree or an equivalent combination of education and work experience required.
• Minimum 10 years of experience in quality required, with at least 5 years management of demonstrated compliance excellence, value improvement, and risk reduction.
• Demonstrated experience with Domestic and International regulatory requirements and regulating bodies required for In-Vitro Diagnostics or Medical Devices
• Strong leadership skills with demonstrated ability to create momentum and deliver excellent results.
• Strong project management, team skills, and influential management.
• Ability to work in a highly matrixed and geographically diverse, and fast-paced environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization and with regulators
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.

Preferred Skills and Experience

• MS degree preferred.
• Prior experience in Molecular Diagnostics
• 3+ years prior experience in Complaint Handling, Field Actions, and Adverse Event Reporting for Medical Devices or IVDs to meet international experience