Post Market Risk Management 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, we are seeking a Post Market Risk Management Specialist II to join our Quality Product team. This role will lead critical initiatives and leverage skills and experience to complete tasks with general supervision. This position is based in Rochester, NY.

The Responsibilities

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

• Executes field actions and regulatory authority reporting within the team. Researches, collects data and responds to requests for field action data and risk management evaluations.

• 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.

• Uses the OLAs for Individual Contributors to establish an environment of trust and success.

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

• Perform other work-related duties as assigned.

The IndividualRequired:

• Bachelor’s degree in Science, Engineering, or related field required.

• Minimum of 3 years medical device / IVD or clinical/blood-banking laboratory experience required.

• Must have experience with QMS applications including Windchill.

• Must be able to work complete tasks on time and under general supervision.

The Interactions

Internal Partners: QRC, OrthoCare

External Partners: Vendors, Customers

Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials (up to 10 lbs.) is required. Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception, and ability to adjust focus. While performing the duties of this job, regularly required to use hands to finger, handle, or feel and talk or hear. Frequently required to stand, walk, and sit. Occasionally required to reach, climb or balance. On a typical day, 80% of time is spent at the desk, on the phone, or working at the computer; 20% in meetings or interacting with team members.

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 $80,000 to $100,000. 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 the 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].