Ortho Clinical Diagnostics

  • Senior Engineer, External Manufacturing Quality

    Job Locations MX-Tijuana | MX-BCN-Baja
    Posted Date 1 month ago(19/6/2018 5:03 PM)
    Job Country
  • 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 Senior Supplier Quality Engineer who will be responsible for executing all aspects of Supplier Quality and Compliance, alignment of Suppliers Quality Systems with requirements of the Ortho’s products and QMS and for continuous improvement of suppliers’ quality and compliance performance. Responsible for guidance of suppliers in the effective resolution of supplier related   non-conformances, CAPA and changes. Use appropriate Supplier Quality tools (e.g. Quality Engineering (QE) principles, tools, and practices) to develop and optimize both Ortho’s and the Supplier’s systems and processes, and to identify opportunities to continuously improve quality, cost, and time factors, consistent with Ortho’s business objectives. This position will be a member of Ortho’s External Manufacturing Quality team and provide direct on-site support to Nypro Healthcare in Baja, Mexico.

    The Responsibilities

    • Accountable and responsible for executing all aspects of Supplier and External Manufacturer Quality and Compliance as follows:
    1. Responsible for alignment of Nypro Healthcare Baja’s Quality Management Systems with the requirements of Ortho QMS
    2. Responsible for executing continuous improvement of the quality and compliance performance of Nypro Healthcare Baja
    3. Responsible for providing guidance to Nypro Healthcare Baja in resolution of non-conformances and CAPA in accordance with company processes (including monitoring the effectiveness of Nypro Healthcare Baja’s corrective action responses)
    4. Responsible for quality oversight of all Nypro Healthcare Baja’s generated changes in accordance with company processes, and to ensure that changes are evaluated and implemented in a timely manner
    • Manage Ortho/Nypro Supplier Performance Scorecard process, and analyze and identify emerging supplier non-conformance trends using appropriate statistical tools and presentation of data for Supplier Management Reviews
    • Conduct regular status review meetings with Ortho and Nypro teams to ensure effective and timely resolution of quality issues and trends
    • Perform periodic audits/assessments of Nypro Quality Systems for the purpose of assuring continued Supplier conformance to the quality system requirements. Ensures effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues
    • Provide compliance support for internal and external audits, including support of audit preparation as well as support for investigations and corrective actions stemming from audit observations as required
    • Participates with Ortho EMQ organization on policy/procedure/ guideline development, includes incorporation of this information into programs through document reviews, protocol reviews, validation reviews, and training programs
    • Responsible for the development, implementation and approval of sampling plans, test procedures for products and services sourced from Nypro Healthcare Baja to demonstrate alignments to the final product specifications

    The Individual


    • Bachelor’s degree in Science, Engineering, Statistics, or other related field
    • A minimum of 8 years’ experience in the Pharmaceutical, Medical Device or Biotech Industry with a strong preference for leadership experience in a functional Quality role
    • Bilingual is required. Must be fluent to read, write, and speak English and Spanish
    • Must have unrestricted authorization to work and travel in the US and Mexico
    • Experience as a quality system auditor is required.  Experience in handling external and internal regulatory inspections is required
    • Experience as a validation engineer is preferred (facilities, manufacturing equipment and processes and software validation)
    • Experience as a quality engineer, including risk management/risk-based analysis, nonconformance, root cause investigation and corrective/preventive action is required.  Experience in FMEA or FTA is required
    • Expert understanding/training in FDA CFR Part 820, Part 11, and ISO 130485 regulations is required.
    • Working knowledge of COFEPRIS regulations and requirements

    Other Preferred Skills: 

    • Experience working in Mexico supporting US based operations.
    • Prior Supplier Quality experience in manufacturing and analytic approach to problem solving including the use of Supplier Quality Engineering tools.
    • Must be a critical thinker and active listener with good time management skills in order to work with Suppliers and Project Management teams to define deliverables
    • ASQ CQE/CQA certification a plus
    • Strong project management skills
    • Strong problem solving skills
    • Advanced oral and written communication skills, including the ability to write technical reports and presentations
    • Advanced knowledge of quality related tools including, but not limited to, SPC, AQP, DOE and Quality Systems
    • Proven leadership skills
    • Self-starter with the ability to quickly learn about new processes with very little information provided
    • Lean/Six Sigma training (Certification preferred)
    • Excel Macro programming skills.
    • Up to 30% domestic and/or international travel

    NOTE: This position will be geographically located in Baja Mexico. The candidate may live in US or Mexico and must be able to have unrestricted access to travel in these countries. The candidate will be required to travel to Ortho US based operations for training and other business support needs



    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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