Ortho Clinical Diagnostics

  • Pre Production Quality Engineer

    Job Locations GB-Pencoed
    Posted Date 1 week ago(11/4/2018 10:02 AM)
    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

    As the company continues to grow, we are seeking a skilled Pre-Production Quality Engineer. 


    The main purpose of the post is to lead and execute projects and product trials to ensure that Company quality standards for those products are met and product claims are complied with and to investigate and propose technical solutions to factory/product issues arising from PPQE’s internal/external customers.


    The Responsibilities

    Generic Roles and Responsibilities

    • Identifies, develops, recommends, and implements technical and process improvement. Assesses current systems and recommends improvements.
    • Demonstrates knowledge of limited operational processes affecting product quality and process performance in the quality system.
    • Participates in cross-functional process improvement teams using process excellence tools.
    • Ability to manage multiple tasks and priorities with minimal supervision.


    Job Specific Roles and Responsibilities

    • Plan, assist in the design phase and implement multiple product trials and other projects within agreed procedures, protocols and to agreed timescales.
    • Produce relevant technical reports for both approved validation protocols and “one-off” validations and obtain approvals via the Company systems.
    • Investigate, propose solutions, derive action plans and provide QRC advice and support on technical issues arising from PPQEs internal/external customers.
    • Investigate, design experiments, analyse and provide data and propose methods and action plans for closure of deviations, with focus on prevention.
    • Ensure that staff working on the PPQE projects and trials are clear about the objectives and implement the relevant actions according to agreed procedures and timescales.

    QE Technical Competencies

    • Demonstrates working knowledge of current and applicable GMP regulations eg: ISO13485 / 21 CFR Part 820
    • Demonstrates understanding and application of basic QE tools: SIPOC, Process mapping, FMEA, 5 Whys, Ishikawa diagram
    • Demonstrates use of basic statistical tools: Descriptive statistical charts, ANOVA, t-test
    • Demonstrates competence to assess product and non-product risk based on expectations of SOP22851 and SOP50158.
    • Utilizes risk management and process excellence tools in order to identify risk factors in the quality system. Works with supervisors and others to determine mitigation plans.

    The Individual

    • Minimum of HNC or equivalent in Chemistry, Biochemistry, Biology or Chemical Engineering discipline or equivalent by on-the-job technical experience (3 years)

    • 2- 5 years quality, regulatory and/or compliance experience in a highly regulated manufacturing environment including experience in diagnostics.
    • Detailed knowledge of a majority of operational processes. Basic knowledge of scheduling, shop floor management and workflow processes and their impact on business performance.


    Ability to work on multiple activities

    Supports peers and works well within team 

    Awareness of assay portfolio and companion assays


    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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