Post Market Risk Management Senior Engineer

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 s Sr. Post Market Risk Management Engineer that will work towards proficiency in becoming a subject matter expert in post-market surveillance, risk management and the management of recalls.  They are accountable for the success of compiling, writing, analyzing and submitting necessary post-market surveillance (PMS) data and reports such as Peridoc Safety Update Reports (PSURs), Post-market Performance Follow-ups (PMPFs), recall reports, etc. and will have critical organizational and technical knowledge.  They operate under minimal direct supervision and provide independent guidance to the business

This will be an onsite position in our Rochester, NY location.

The Position

• Provide surveillance guidance to business partners on post market product safety and quality issues (such as for QSMRs, etc.).
• Researches, collects data and responds to requests for surveillance and risk management data evaluations and recalls.
• Compiles, writes, analyzes and submits necessary post-market surveillance (PMS) data and reports such as Periodic Safety Update Reports (PSURs), Post-market Performance Follow-ups (PMPFs), and recall reports to Regulatory Authorities around the world, etc. ​
• Facilitate escalation of safety and quality issues based on Escalation Pathway and surveillance data.
• Act as SME in internal and external audits.
• Posses behavior is consistent with the Leadership Attributes for Individual Contributors.
• Establish a high performance and continuous process improvement culture, driven by metrics, benchmarking and best practice.
• Perform other work-related duties as assigned.

The Individual

Required:

• Bachelor's degree in Science or Engineering.
• A minimum of 4 years medical device / IVD or clinical/blood-banking  experience. 
• Previous experience in a quality or regulatory role; or equivalent combination of education and experience.
• This position is not currently eligible for visa sponsorship. 

The Key Stakeholders

Internal Partners:

• CHU, QRC, QRA, OrthoCare, R&D, Operations (Logistics/Supply Chain/Product Support), Commercial/Marketing

External Partners:

• Regulatory Authorities, Notified Bodies/Competent Authorities

The Work Environment

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel.

Physical Demands

No strenuous physical activity, though occasional light lifting of files and related materials is required. 30% of time in meetings, working with team, or talking on the phone, 70% of the time at the desk on computer, doing analytical work. Minimal travel required. Travel includes airplane, automobile travel and overnight hotel.

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 $105,000-$115,000 [and is bonus eligible or eligible for incentive compensation.] 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].