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.
Quality Engineer II
As QuidelOrtho continues to grow, we are seeking to appoint a Quality Engineer II to join our Quality Operations department in Pencoed on a permanent basis. This role will work on a day’s basis Monday to Friday, with some weekend days’ work required which will be on a rotation basis between the team (One weekend out of every four – days only).
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:
As a Quality Engineer II at QuidelOrtho, you will provide compliance and technical support to Manufacturing on all aspects of the Immunoassay and Immunohaematology manufacturing process controls at the Pencoed manufacturing site.
You will be utilising key Quality Engineering (QE) principles, tools, and practices to develop and optimise process controls and quality system processes that are aligned with the overall business goals and QuidelOrtho’s Quality Policy.
What You’ll Be Doing:
- Partner with manufacturing to address quality events including attending and documenting rapid response events, non-conformances, product disposition. Facilitating and documenting risk assessment when appropriate.
- Quality representative for teams conducting investigations related to non-conformances and/or customer complaints. Escalate issues per established procedures. Apply CAPA process through completion and approval of non-conformances, RCI and CAPA.
- Demonstrate problem-solving skills. Identifies and resolves problems in a timely manner. Gathers and analyzes information skilfully. Develops alternative solutions effectively analyzes technical data and proposals.
- Provide support for maintenance of device history record through review of quality logs, bonding and debonding of material through electronic stock management systems.
- Track and trend quality data for non-conformances, RCI, CAPA and Change Control. Maintenance of quality data in Enterprise Resource Planning software.
- Provide quality engineering support to project teams in compliance with FDA, ISO and CMDR regulations and QuidelOrtho Quality System requirements.
What You’ll Need to Succeed:
- A bachelor’s degree in Chemistry, Biochemistry, Biology, Chemical Engineering, or another related discipline OR related relevant experience is required.
- Minimum of 3 years’ experience in Quality, Regulatory and/or a highly regulated manufacturing environment (Diagnostics, Medical Devices, Pharmaceuticals or Consumer).
- Understanding of non-conformances, CAPA records and conducting RCI.
- Confidence in your problem-solving abilities, and comfortable taking responsibility for decisions.
- Experience working and communicating effectively with various business partners.
- Experience supporting with both internal and external audits is desirable.
- Ability to work the shift pattern (one weekend out of every four – days only).
What we offer:
- Competitive Salary
- Yearly Salary Reviews
- Attractive Pension Scheme
- Bonus Scheme
- Life Assurance
- Private Medical (If applicable)
- LinkedIn Learning
- Cycle to Work Scheme
- Free Onsite Gym
- Subsidised Canteen
- 25 days Holidays + 8 Bank Holidays (Milestone Increases Available)
- Employee Assistance Programme
- Reward & Recognition Programmes
- State-Of-The-Art facilities
- Exceptional career developmental prospects
- Strong culture centred around collaboration & customer focus.
#LI-RP1
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.
