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 2 to complete complaint management process and play a role in the other types of investigations carried out by the Complaint Handling Unit. They 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 as required. Ability to carry out various activities while consistently maintaining accuracy and attention to detail. This is an individual contributor who has the ability to work independently and whose job requires independent judgment and decision-making within the limits of established policies and procedures. Good communication with other team members and peers to allow work to be carried out in a timely manner.

　　We are seeking:

　　An experienced professional in investigational or quality work areas; resolves a wide range of issues in creative ways

　　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.

　　This is an onsite role in our Rochester, NJ location.

　　The ResponsibilitiesExecutes complaint investigation, Failure Investigations and vigilance reporting within the team. Researches, collects data and responds to requests for vigilance reporting, health hazard evaluations and post market surveillance reports.

　　Assists business partners on post market product safety and quality issues.

　　Participates in projects as team member with specific identified deliverables.

　　Supports a continuous improvement culture with a focus on metrics, benchmarking and best practices.

　　Provides support during internal and external audits. May be required as SME.

　　Provides input and support during escalation of safety and quality issues based on surveillance data.

　　Maintains appropriate measures and indicators to support a high performance and continuous process improvement culture.

　　Performs other duties & projects as assigned.

　　The IndividualBachelor's Degree in Science or Engineering or equivalent.

　　A minimum of 2 years of work experience - preferred medical device / IVD or clinical/blood-banking laboratory experience. Preferred previous experience in a quality or regulatory role.

　　Key Working Relationships

　　Internal: QRC, QRA, OrthoCare, Operations Teams.

　　The Work Environment Combination of operations and desk environment.

　　Salary Transparency

　　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 $53,000 to $96,000 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.

　　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].

　　#LI-AK1

　　Equal employment opportunities for all employees. We fulfills this commitment through a variety of measures including internal & external posting of job openings, hiring, training & promoting individuals without regard to race, color, religion, sex, pregnancy, national origin, ancestry, citizenship, veteran status, disability, medical condition, marital or domestic partner status, sexual orientation, gender identity, age,or any other considerations made unlawful by federal,state or local law

　　Minimum Salary: 53000.00Maximum Salary: 96000.00Salary Unit: Yearly