Ortho Clinical Diagnostics

Senior Quality Engineer

Job Locations GB-Pencoed
Posted Date 3 weeks ago(23/2/2018 5:46 PM)
Job Country
United Kingdom

The Company

Ortho Clinical Diagnostics (Ortho) is a global leader of in vitro diagnostics.  Ortho serves two primary industries in the medical field: clinical laboratories, by producing platforms and assays that test for a variety of diseases, conditions, and substances; and immunohematology, by providing the means to ensure blood transfusion recipients receive appropriate and compatible blood.


With a history of more than 75 years, Ortho is a pioneer in life-impacting advances in diagnostics. Worldwide across hospitals, hospital networks, blood banks and labs, Ortho’s high-quality products and services enable health care professionals to make better-informed treatment decisions. Headquartered in Raritan, NJ, Ortho Clinical Diagnostics has approximately 4,300 employees serving customers in more than 120 countries.


Ortho is recruiting and retaining the best and brightest around the world. People, who are performance driven, want to make a difference and who help Ortho grow their leadership position in a changing marketplace. The power to reimagine starts with empowered people, who are empowered to grow and given the chance to succeed in ways they hadn’t thought possible before.


Ortho’s purpose is simple: to improve and save lives with diagnostics. They do that by reimagining what’s possible. It’s what defines them. It’s the Ortho difference.


Ortho is an independent company, sponsored by The Carlyle Group, one of the world’s largest and most successful investment firms. The company's executive leadership team has extensive diagnostic experience and a strong heritage of driving market change and innovation. Ortho is a strong brand with solid positions in attractive, growing segments and regions.

The Career Potential

Ortho Clinical Diagnostics is committed to improving and saving lives with diagnostics. To do this we hire people who share this dream and are ready for new adventures. As a valued team member, you will carve your own career path and be part of building this company stronger and better than ever before. There is no limit to the experiences, opportunities and new directions you will have access to here at Ortho Clinical Diagnostics. More importantly, you will be driving the surge of a whole new direction in important medicine. That’s something we can all take pride in as we take this journey together.


Ortho is known in the industry as a leader in customer service and support.  Deeply understanding and exceeding the needs of our clinical lab, hospital and blood bank customers is what we do.  It’s who we are.  If you join Ortho, no matter what your role, you will be expected to keep that Customer Excellence focus in your work.

The Opportunity

There following opportunities are available within the QE Green team:

              - Permanent Senior QE

            - Temporary Secondment/Contract – Senior QE


In this position you would have oversight of all quality elements of ≥1 manufacturing Work Centres. Analysing and trending available data and using Process Excellence tools and risk based/data driven decision making to drive improvements. Also ensuring that the validated state of the assigned WorkCentre is maintained.

The Responsibilities

  • Provide root cause investigation and CAPA support for work centre. Including identification and execution of Corrective Action, Preventive Action and Effectiveness monitoring plans.
  • Development of sampling plans based on statistically sound rationale for use in testing for Validation, Disposition and Effectiveness monitoring activities.
  • Accountable for the preparation and issuance of Validation Plans, Protocols, Summary Reports and associated documentation for complex projects such as installation of new plant equipment, or significant supplier change.
  • Use risk based/data driven decision making to disposition non-conforming product. Understanding the needs of the customer, the clinical implications of the risk and the regulatory requirements. Developing strategies for complex disposition requirements.
  • Support project teams and provide the face of quality in terms of validation and quality requirements.
  • Use innovative thinking to drive simplifications to the quality processes with no impact to compliance. Identify and lead improvements which have impact within and outside of QE.

The Individual


  • Minimum degree (or equivalent experience) in in science related discipline
  • Proven, well-developed quality, Regulatory and/or compliance experience in a highly regulated manufacturing environment
  • Lean management six sigma understanding. Use of tools in every day decision making
  • Ability to prioritize and manage risk. Demonstration of risk based decision making within product release or CIP/project background
  • Working level of computer literacy including Microsoft Office tools
  • Excellent verbal and written communication skills


  • Experience working in a diagnostic field
  • Green / Black belt training
  • Data analysis using Minitab



Equal Opportunity

At Ortho Clinical Diagnostics, we are proud of the empowering, inclusive and innovative culture we are growing. Our team is passionate about our work, and brings deep knowledge, industry experience and diverse thinking that drive results, making Ortho a place to grow your career. 


Ortho Clinical Diagnostics is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other characteristic protected by law.

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