Complaint Handling Specialist - Athens Ohio

Company: Ortho Clinical Diagnostics
Location: Athens, Ohio
Posted On: 04/24/2024

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

The Complaint Handling Specialist supports activities in the Quality Operations department as defined by the Quality Management System (QMS) and within defined company policies, procedures, and regulatory requirements. They are key members on critical initiatives and will manage routine processes and sets of tasks in addition to contributing work and knowledge within larger projects. They operate under minimal supervision and provide assistance and support to the business. This is an individual contributor who works independently and whose job requires a large degree of independent judgment and decision-making within the limits of established policies and procedures.

This role is located in Athens, Ohio.

The Responsibilities

• Assists business partners on post market product safety and quality issues.
  
• Oversees complaint investigation process, Failure Investigations, and vigilance reporting for the Site. Researches, collects data, and responds to requests for vigilance reporting, health hazard evaluations and post-market surveillance reports.
  
• Participates in projects as team member with specific identified deliverables, with a focus on metrics, benchmarking, and best practices.
  
• Provides input and support during escalation of safety and quality issues based on surveillance data.
  
• Develops and maintains procedures and metrics associated with monitoring released product performance and post-market analysis.
  
• Conducts complaint review and trend analysis for adverse events and/or trends and where necessary, initiates corrective action.
  
• Schedules, prepares, and presents at complaint review meetings.
  
• Provides support during internal and external audits. May be required as SME.
  
• Maintains appropriate measures and indicators to support a high performance and continuous process improvement culture.
  
• Develops and maintains metrics and performs analysis in support of Management Review and monthly Operations meetings, as related to QA processes specifically for change control, internal audits, customer complaints, corrective and preventive actions, and other areas as deemed necessary.
  
• Supports department personnel in achieving objectives in support of the vision and mission of the corporation and department.
  
• Perform other work-related duties as assigned.
  The Individual
  
  Required:
  • Bachelor's degree or Associate's degree in Science or Engineering or an equivalent combination of education and experience
    
  • Quality and customer-focused mindset that drives risk-based decisions to resolve potential health & safety issues and product quality issues.
    
  • Works on problems of diverse scope where analysis of data is required to establish root/assignable cause(s).
    
  • Manages the coordination, compilation and submission of reports to Health Authorities.
    
  • Collaborates with cross-functional partners to develop solutions to a variety of complex problems within the constraints of established procedures.
    
  • Supports internal/external audit activities and process improvement initiatives.
    
  • Must be highly skilled in typical computer systems and software, including proficiency in MS Office suite (e.g. Excel, Word, PowerPoint) and Adobe programs.
    Preferred:
    • 1-3 years of work experience - medical device / IVD or clinical/blood-banking laboratory experience. Previous experience in a quality or regulatory role.
      
    • Working knowledge of FDA Quality System regulation and ISO 13485 standard.
      
    • Knowledge of statistical analysis techniques
      
      
      The Key Working Relationships
      
      Internal Partners:
      
      Technical Support, QRC, Business Unit, R&D, Operations
      
      The Work Environment
      
      The work environment characteristics are representative of both an office and manufacturing environment.
      
      Equal Employment 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 recruiting@quidelortho.com.
      
      #LI-HF1 More...

          

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