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.
Post-Market Risk Management (PMRM) Specialist
As QuidelOrtho continues to grow, we are seeking a Post Market Risk Management (PMRM) Specialist to join our team on a permanent basis. The PMRM Specialist acts as a member on critical initiatives, adhering to routine processes and sets of tasks. In addition to contributing work and knowledge to projects.
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. Onsite 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.
What you'll be doing:
- 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.
- Maintains appropriate measures and indicators to support a high performance and continuous process improvement culture.
- Other work-related duties as assigned.
What you'll need to succeed:
- Educated to a minimum of a degree level in a Science or Engineering related subject; or relevant experience within a quality or regulatory role within a similar environment.
- Previous experience in Medical Device / IVD industry or clinical/blood-banking laboratory environment is required.
- Strong planning, communication & collaboration skills are essential.
What we’re offering:
- Competitive Salary.
- Attractive Pension Scheme.
- Bonus Scheme.
- LinkedIn Learning
- Life Assurance.
- Private Medical
- Cycle to Work Scheme.
- Free Onsite Gym.
- 25 days Holidays + 8 Bank Holidays (Milestone Increases Available).
- Employee Assistance Programme.
- Reward & Recognition Programmes.
- Exceptional career developmental prospects.
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What We Do
Ortho Clinical Diagnostics (Nasdaq: OCDX) is one of the world’s largest pure-play in vitro diagnostics (IVD) companies dedicated to transforming patient care. More than 800,000 patients across the world are impacted by Ortho’s tests each day. Because Every Test is a Life, Ortho provides hospitals, hospital networks, clinical laboratories and blood banks around the world with innovative technology and tools to ensure test results are fast, accurate, and reliable. Ortho's customized solutions enhance clinical outcomes, improve efficiency, overcome lab staffing challenges and reduce costs. From launching the first product to determine Rh+ or Rh- blood type, developing the world’s first tests for the detection of antibodies against HIV and hepatitis C, introducing patented dry-slide technology and marketing the first U.S. Food and Drug Administration-authorized high-volume antibody and antigen tests for COVID-19, Ortho has been a pioneering leader in the IVD space for over 80 years. The company is powered by Ortho Care, an award-winning, holistic service and support program that ensures best-in-class technical, field and remote service and inventory support to laboratories in more than 130 countries and territories around the globe.
