Customer Quality Manager - Recalls and Device Tracking

March 18

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LivaNova

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LivaNova PLC is a global medical technology company built on nearly five decades of experience and a relentless commitment to improve the lives of patients around the world. Our advanced technologies and breakthrough treatments provide meaningful solutions for the benefit of patients, healthcare professionals and healthcare systems.

medical devices • neuromodulation • Cardiac Surgery

1001 - 5000 employees

📋 Description

• Leads the development, implementation and maintenance of Device Tracking and Recalls for LivaNova’s Neuromodulation business unit • Oversees the timely and effective implementation of recalls (corrections and removals) around the world and the device tracking of neuromodulation devices • Establishes and maintains procedures and processes related to recall implementation and reporting and Device Tracking • Interactions with external industry or regulatory bodies including presentation of areas of responsibility as subject matter expert during inspections • Monitors department performance versus key performance indicators and reports on this performance to site and executive leadership • Leads, manages and develops direct reports by preparing objectives and metrics, communicating expectations, improving technical capabilities and measuring results against these goals • Implements procedures to ensure compliance with ever-changing worldwide regulations • Leads effective meetings, conducts presentations, keeps quality records • Maintains robust employee training programs related to device technology and customer-related processes • Defines and implements initiatives to enhance system efficiencies, productivity, and quality that are consistent with company changes and growth • Supports and implements such changes without adversely impacting quality or regulatory compliance • Develops and maintain effective relationships with internal personnel and external stakeholders to assist customers and drive the resolution of customer complaints • Performs other duties as may be required by the manager.

🎯 Requirements

• BS in Engineering or Science • > 5 years of experience working in quality within the medical device industry • Proven track record playing a significant role in executing worldwide medical device recalls • Experience interacting directly with regulatory authorities, through in-person and/or written communications • Proficient in MS Office including Word, Power Point, and Excel • Strong interpersonal skills and excellent written and verbal communication skills • Ability to prioritize and plan activities of self and direct reports • Resolves most issues with peers, but understands what issues are important to escalate to senior management • Possesses in depth knowledge of applicable standards/regulations (e.g., EU MDR, AIMDD, ISO 13485, 21 CFR 806, 21 CFR 820, and 21 CFR 821) to ensure the documentation of functions meet these requirements and, when necessary, identify compliant, effective and efficient approaches to fulfilling such requirements • Familiarity with medical terminology.