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.

Senior Post Market Risk Management Engineer

As QuidelOrtho continues to grow, we are seeking to appoint a Senior Post Market Risk Management (PMRM) Engineer to join our Post Market Risk Management department at our Pencoed site on a permanent basis.

About QuidelOrtho, Pencoed

QuidelOrtho has been manufacturing products in South Wales for over 40 years. Our state-of-the-art manufacturing facility, based in Pencoed, employs over 600 people who are involved in the manufacture and supply of clinical laboratory and immunohematology products to sites across the globe.

Our Pencoed team manufacture a large menu of immunohematology products used in transfusion medicine; in addition to a large menu of immunoassay products encompassing a range of disease categories.

On site we have a range of functions operating globally & locally. All our employees are working towards one common goal, to help save and improve lives through diagnostics.

Your new role:

This position will work towards proficiency in becoming a subject matter expert in post-market surveillance, risk management and the management of recalls.  You will be accountable for the success of compiling, writing, analysing and submitting necessary post-market surveillance (PMS) data and reports such as Periodic Safety Update Reports (PSURs), Post-market Performance Follow-ups (PMPFs), recall reports, etc. and will have critical organizational and technical knowledge.  You will operate under minimal direct supervision and provide independent guidance to the business.

What You’ll Be Doing:

Provide surveillance guidance to business partners on post market product safety and quality issues (such as for QSMRs, etc.)Research, collect data and respond to requests for surveillance and risk management data evaluations and recallsCompile, write, analyse and submit 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 dataAct as SME in internal and external auditsEstablish a high performance and continuous process improvement culture, driven by metrics, benchmarking and best practicePerform other work-related duties as assigned

What You’ll Need to Succeed:

Bachelor’s degree in science or engineeringRelevant medical device / IVD or clinical/blood-banking experience Previous experience in a quality or regulatory role; or equivalent combination of education and experience

What we offer:

Competitive SalaryYearly Salary ReviewsAttractive Pension SchemeBonus SchemeLife AssurancePrivate Medical (If applicable)LinkedIn LearningCycle to Work SchemeFree Onsite GymSubsidised Canteen25 days Holidays + 1 QuidelOrtho Day + 8 Bank Holidays (Milestone Increases Available)Employee Assistance ProgrammeReward & Recognition ProgrammesState-Of-The-Art facilitiesExceptional career developmental prospectsStrong culture centred around collaboration & customer focus.

#LI-RP1