Vyaire Medical Senior Manager, Complaints and Post-Market Surveillance in Mettawa, Illinois
Senior Manager, Complaints and Post-Market Surveillance
At Vyaire, we help the world breathe easier. As a global leader in respiratory care, we know what we do enables, improves and extends lives. We are a young company with a long history of revolutionary products. We devise extraordinary solutions that allow patients to lead ordinary lives. We believe the best way to create value for our customers, is to become invaluable. We know a dynamic culture with diversity of thought makes this possible. Our colleagues are people who specialize in exceeding expectations, building lasting relationships and making it a priority to listen. We are dedicated to anticipating what’s next and get it done. We thrive on contributing and making a difference.
To learn more, visit our website: www.vyaire.com
Watch our video: https://www.youtube.com/watch?v=ZDrQoMbMRrI&feature=youtu.be
About this role
Vyaire teams are dedicated to connecting clinicians and patients with the highest quality respiratory healthcare solutions in the market. At Vyaire, you will find a company that puts the customer at the center of all we do. Our culture is one that rewards performance and each interaction we have with a customer furthers our mission to be the global leader in respiratory care.
As the Senior Manager Complaints & Post Market Surveillance, you will report to the Vice President of Quality Assurance and Regulatory Affairs, and manage a team of 12 people in complaint management, quality reporting and risk management as well as manage the technology infrastructure for complaints. The team is the customer facing department responsible for managing the customer experience through feedback on our products and services. They are responsible for customer complaint lifecycle management, monitoring product/service quality through the complaint process, working with our failure analysis labs to drive resolution to customer complaints, regulatory reporting, FSCAs/recalls and facilitating continuous improvement driven by complaint data, trending, and analysis.
Manage the team responsible for the process related to complaint intake, review, evaluation, and documentation of the decision-making rationale regarding regulatory reporting, investigation, corrective action determination, evaluation of management escalation and timely closure of complaint files within the complaint handling software system.
Ensure Post-Market compliance to EU MDR and other evolving regulatory requirements
Effectively manage external vendor relationships and remote team members
Facilitate sample return and investigation by suppliers
Participate and support internal and external audits and inspections
Lead cross-functional customer care meetings to present and review post-market product surveillance data
Provide guidance on post market data analysis and trending
Project manage Quality Assurance and/or Regulatory Affairs projects including end-to-end implementation and enhancements of global systems used for quality and regulatory compliance
Manage the complaints management system (i.e., MedVantage) as well as supporting software and algorithms to drive scalability and improvements in complaint management
Responsible for Computer Software Validation of global systems used for quality and regulatory compliance
Monitor effectiveness of established complaints processes. Utilize continuous improvement tools to drive compliance and effective processes
Ensures teams meet regulatory requirements related to timely reporting, accurate and comprehensive medical device reporting and follow-up, timely and comprehensive response to FDA/Competent Authority inquiries, and other global governmental agency request.
Ensures teams are addressing critical customer needs and maintains best in class standards for grade of service and time to resolution.
Develops the necessary department goals and objectives. Manages departmental priorities and ensure the necessary resources are identified.
Responsible for developing relationships with key internal and external customers to identify, facilitate, strategize, and prioritize the necessary activities in order to meet the business objectives.
Carries out managerial responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and managing work; appraising performance, motivating, rewarding, and disciplining employees; addressing complaints and resolving problems.
Perform other duties as assigned.
Bachelors of Science degree required
Minimum seven (7) years in a quality systems or regulatory affairs role within a medical device, pharmaceutical, and/or medical diagnostics company
Experience in eQMS implementation and validation
Experience with Quality system including Risk Management, Doc control, Complaint processing, CAPA, and internal audits
Experience with post market surveillance and regulatory reporting
Experience with ISO 13485, FDA QSR/GMPs, and FDA inspections
Leading and managing a team of exempt employees
ASQ/RAC certification(s) preferred
Experience lead enterprise and TQM programs
Possess sounds judgment and decision-making capabilities in technical, business, and regulatory compliance arenas, with strong expertise of domestic and international regulatory compliance requirements
Must be capable of interfacing with executive level of management and health care professionals
Atlanta, GA, Houston, TX, Irvine, CA, Mettawa, IL
We aspire to a “higher calling” , aligning ourselves with healthcare providers to improve the lives of those who are treated with our devices.
Across the Ventilation, Respiratory Diagnostics and Anesthesia Delivery & Patient Monitoring market segments, we represent the largest pure-play company of our kind, with an ambitious and innovative vision for growth. We hold each other mutually accountable for the quality and reliability of our products and work together toward setting a new market standard in these categories.
We are transforming the future of respiratory care; explore how you can be a part of it.
We are a unified “breathing company”, with a global team that is unrivaled in the respiratory care continuum. Each of our 5,000 people worldwide is critical to achieving our shared purpose of improving the lives of those who are treated with our devices. Our people are empowered to “do the right thing” every day and always put patients first. Our market presence, breadth of product and technical expertise enable us to impact the lives of patients around the world every day.
One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person’s race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.
One of our unique strengths is the diversity of our community. We want to treat each teammate fairly and provide equal employment opportunities regardless of a person's race, color, religion, gender or gender identity, sexual orientation, age, marital status, national origin, veteran or disability status, or any other characteristic.
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