Senior Manager, Complaint Handling and Customer Monitoring

QuidelOrtho•Raritan, NJ

17h•Hybrid

About The Position

QuidelOrtho unites the strengths of Quidel Corporation and Ortho Clinical Diagnostics, creating a world-leading in vitro diagnostics company with award-winning expertise in immunoassay and molecular testing, clinical chemistry and transfusion medicine. We are more than 6,000 strong and do business in over 130 countries, providing answers with fast, accurate and consistent testing where and when they are needed most – home to hospital, lab to clinic. Our culture puts our team members first and prioritizes actions that support happiness, inspiration and engagement. We strive to build meaningful connections with each other as we believe that employee happiness and business success are linked. Join us in our mission to transform the power of diagnostics into a healthier future for all. The Role As we continue to grow as one QuidelOrtho, we are seeking a Senior Manager, Complaint Handling and Customer Monitoring to work in our Raritan New Jersey facility. The Senior Manager, Complaint Handling and Customer Monitoring is responsible for the global implementation of the complaint management elements of the QuidelOrtho Quality Management System at the company level. This is a global leadership role engaged in the oversight of the complaint trending, investigation and escalation processes. This position is in Raritan, New Jersey.

Requirements

Bachelor’s degree in Science or Engineering.
A minimum of 10 years medical device / IVD or clinical/blood-banking laboratory experience.
Previous experience in a quality or regulatory management role including previous line management of professional grade staff.
Experience of interfacing directly with health authorities / regulatory bodies.
Partners with business leaders to translate strategy into improvements in customer excellence, process efficiency and regulatory compliance.
Ensures flawless execution of complaint handling requirements to ensure the business meets global Heath.

Nice To Haves

Ability to actively participates in Leadership forums and provides leadership, coaching and mentoring to the broader organization.
Ability to partner closely with R&D, Global Services, Operations, External Operations and other QuidelOrtho functional teams, as well as, key external manufacturing business partners to supporting goal and objectives.
Ability to effectively negotiate and influence senior management, to secure resources and funding to execute and plan key process and product projects.
Possesses strong conflict resolution, change management, communication (written and verbal), organizational management.
Business ethics and analytical reasoning skills and demonstrates the ability to work in a diverse cross-functional, cross-company environment.

Responsibilities

Providing Product Quality insights for internal stakeholders.
Ensuring that the business initiates complaint investigations in a timely manner based on signal detection and as necessary escalation through the escalation process including recommendations for CAPA.
Ongoing assessment of industry trends and evolution of regulatory requirements to ensure continued inspection readiness and compliance with Global Health Authority Regulations.
Balancing the tactical and more strategic elements of the role including identification and execution of continuous improvement programs to deliver against business objective.
Performs other duties & projects as assigned.
Manages, oversees and balances resource allocation within the global team.
Develops Annual Operating Plan (AOP) in partnership with Finance and ensures execution against the Financial Plan.
Escalates and addresses safety and quality issues and advises on matters of product quality.
Plays lead role in back room support during internal and external audits, may also be front room SME.
Ensures that staff are appropriately trained & developed.
Provides leadership of a high performance and continuous process improvement culture, driven by metrics, benchmarking and best practice.