Ortho Clinical Diagnostics

  • Head of Product Design & Surveillance

    Job Locations US-NY-Rochester | US-NJ-Raritan | GB
    Posted Date 2 months ago(8/2/2018 2:46 PM)
    Job Country
    United States
  • 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 Head of Product Design Quality & Surveillance.


    This position will be responsible for providing the overall leadership for the Product Design Quality & Surveillance Organization focused on Quality oversight over the new product development process (design control), changes to on market product (design change), continued assessment of on market quality (product surveillance and failure investigation) and Quality oversight of External Manufacturer’s. The role will demand the leadership of a diverse pool of talent located at multiple Ortho facilities focused at a Business Field level on the quality of products manufactured and/or distributed by Ortho in close partnership with the R&D Business Field, Ortho Care, Procurement and Supplier Engineering organizations.


    The role will ensure that Ortho’s products are developed and maintained in compliance with Design Control regulations and expediency of investigation and implementation of CAPA in response to signals from the field including but not limited to complaint trending data. Furthermore the role will be focused on the overall quality relationship and oversight of Ortho’s External Manufacturing partners and corporate distributors through partner selection, monitoring, development, change management and supplier NC / CAPA.


    The role will demand development and execution of continuous improvements in Ortho’s Design Control processes, assessment of on market quality and failure investigation process to deliver business efficiencies and enable greater organizational agility and velocity. These improvements will enable greater market access to new and improved Ortho products and greater responsiveness to on market signals through identification of root cause and implementation of corrections, corrective and preventative actions. The role will also require continued development of the supplier management processes to maintain compliance with Purchasing Control regulations, drive proactive improvements in externally sourced finished goods and services while delivering overall efficiencies to the organization.


    Furthermore the role will demand development of data insights to enable the organization to transition from a reactive to proactive approach to the management of overall Ortho Product Performance in partnership with key business partners. Finally the role will also demand close partnerships with external partners engaged in the development, manufacture and provision of products for distribution by Ortho.


    The Responsibilities

    • Provides leadership in the development and execution of strategies to drive efficiencies in the Design Control process to reduce cost and/or enhance speed to market of new products and product enhancements. Ensures effective partnership with the R&D organization to ensure alignment on strategy, goals and objectives and portfolio prioritization.
    • Lead team in the overall Quality Management and oversight of a Business Field portfolio of externally manufactured goods and services. Maintains overall Quality Relationship with external supply base in line with defined Quality agreements driving improvements in product quality and associated quality metrics / indicators.
    • Leads the team to improve insights into overall Product Quality & Health through development of data analytics using data sources including but not limited to complaint, EConn and reliability data. Utilizes these data sources to partner with R&D to ensure appropriate response to Product Quality issues while developing a predictive, proactive approach to management of Product Quality. In partnership with key business partners’ drives prioritization and transparency to issues managed within the Failure Investigation Process. Drives rigor and efficiencies in the investigation processes to improve responsiveness to customer product quality issues ensuring CAPA is adequately scoped, effective and aligned with customer needs and expectations.
    • Responsible for development of organizational strategy, goal development and development of overall organizational competency to meet the current and future needs of the business. Manages budgets and resource planning in response to business needs and priorities.
    • Ensure that Design Control, Purchasing Controls, Product Surveillance and Failure Investigation processes, tools and supporting data analytics meet the needs of the business. Champions the application of benchmarked best practices to deliver business efficiencies while driving improvements in overall compliance to Quality Systems Regulations.
    • Collaborates with other QRC groups, R&D, Operations and Procurement to ensure successful Regulatory Inspections.
    • Perform other work related duties as assigned. 

    The Individual

    • BA/BS in Life Sciences, Engineering, or Physical Science Required.
    • MA/MS in Life Sciences, Engineering, or Physical Science Preferred.
    • 9 to 12 years related experience in Medical Device quality system management, with experience / knowledge of Design Control, Design Change, Product Surveillance, Root Cause Investigation and CAPA. Desirable certifications include ASQ –CQA, ASQ-CQE, ASQ-SWQE, ASQ-CQM, Process Excellence.
    • 15% Domestic & International travel (WW locations for direct reports; interactions with Suppliers/Development Business partners.
    • Work visa sponsorship is not available for this position.


    Equal Opportunity

    Ortho Clinical Diagnostics believes in Equal Opportunity for all and is committed to ensuring all individuals, including individuals with disabilities, have an opportunity to apply for those positions that they are interested in and qualify for without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, age, veteran status, disability, genetic information, or any other protected characteristic. Ortho Clinical Diagnostics is also committed to providing reasonable accommodations to qualified individuals so that an individual can perform their job related duties. If you are interested in applying for an employment opportunity and require special assistance or an accommodation to apply due to a disability, please contact us at orthorecruiting@orthoclinicaldiagnostics.com.


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