Complaint Handling Specialist II

The Opportunity

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 QuidelOrtho, we are seeking a Complaint Handling Specialist II. The Complaint Handling Specialist II will be an experienced professional in IVDs and is a key member on critical initiatives. Will manage routine processes and tasks, in addition to providing expertise as part of larger project teams. Will support continuous improvement of quality processes and resolve a wide range of issues in creative ways. As an individual contributor, will work both autonomously and collaboratively, requiring a large degree of independent judgment and decision-making within the limits of established policies and procedures.

This position is in Rochester, NY.

The Responsibilities

• Assists business partners on post market product safety and quality issues.
• Executes Product Quality Investigations within the team. Researches, collects data and responds to requests for Product Quality Investigations, health hazard evaluations and post market surveillance reports.
• Participates in projects as team member with specific identified deliverables.
• Provides input and support during escalation of safety and quality issues based on surveillance data.
• Provides support during internal and external audits. May be required as SME.
• Supports a continuous improvement culture with a focus on metrics, benchmarking and best practices.
• Maintains appropriate measures and indicators to support a high performance and continuous process improvement culture.
• Manages the coordination, compilation and submission of regulatory applications or quality reports.
• Develops solutions to a variety of complex problems. May refer to established precedents and policies.
• Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's Degree in Science, Engineering, or relevant discipline.
• 2+ years of relevant work experience in investigations.
• Less than 5% travel (as needed) - Domestic/International

Preferred:

• Excellent written and verbal communication skills.
• Prior medical device / IVD or clinical / laboratory experience.
• Prior experience in a quality or regulatory role.
• Prior Clinical Laboratory assay product experience.

The Key Working Relationships

• Internal Partners: QRC, QRA, Business Field, OrthoCare, R&D, Operations
• External Partners: Regulatory Auditors / Inspectors

The Work Environment

The work environment characteristics are representative of a typical office environment; no strenuous physical activity, though occasional light lifting of files and related materials is required. 40% of time in meetings, working with the team/other cross functional teams, or talking on the phone, 60% of the time at the desk on computer, providing support for regulatory inspections. Flexible work hours to meet project deadlines as needed. Less than 5% travel (as needed) - Domestic / International.

Equal Opportunity

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 [email protected]

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