Senior Manager, Complaint Handling and Customer Monitoring

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.

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.

• The role is essential in 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.

• The individual in the role must balance 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.

Required:

• 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

• 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

Preferred:

• 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

Internal: Operations, Regulatory Affairs, Medical & Clinical Affairs, Business Unit, Regional Commercial Organizations, Global Services Organization, Product Management, Research and Development, Triage, Life Cycle Management, Technical Quality, Quality Operations, Post Market Surveillance & Risk Management, Field Actions and Reporting

External: Health Authorities, Customers, Distributors, Trade Associates, Professional Bodies

• Workspace: Traditional workspace or remote

• Potential for 10% Travel

• Frequent sitting.

• Frequent typing/ repetitive movement - use of pc keyboard and mouse.

• Occasional standing, walking.

• Occasional lifting/ carrying of items up to 10 lbs (laptop).

• Intermediate Visual Acuity (computer terminal or work within arms reach).

• Occasional travel - airplane/ automobile.

The salary range for this position takes into account a wide range of factors including education, experience, knowledge, skills, geography, and abilities of the candidate, in addition to internal equity and alignment with market data. At QuidelOrtho, it is not typical for an individual to be hired at or near the top range for their role and compensation decisions are dependent on the facts and circumstances of each case. The salary range for this position is $155,000 to $202,000 and is bonus eligible. QuidelOrtho offers a comprehensive benefits package including medical, dental, vision, life, and disability insurance, along with a 401(k) plan, employee assistance program, Employee Stock Purchase Plan, paid time off (including sick time), and paid Holidays. All benefits are non-contractual, and QuidelOrtho may amend, terminate, or enhance the benefits provided, as it deems appropriate.

QuidelOrtho believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. QuidelOrtho is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com

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