Ortho Clinical Diagnostics

Staff Quality Engineer

US-NY-Rochester | US-NJ-Raritan | GB-Pencoed
1 week ago(6/12/2017 11:21 PM)
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.

The Opportunity

As the company continues to grow, we are seeking a Staff Quality Engineer.


This position is responsible to ensure that Ortho products are developed in compliance with OCD Product Delivery & Quality Systems, and worldwide Design Control Regulations, and that subsequent Lifecycle design change controls are effective.  Responsible for completing key outputs which include: documentation to support efficient worldwide regulatory submissions, product risk management, and comprehensive design history.  Required to interface with global manufacturing facilities and external partners for technology transfer of new products and maintenance of Lifecycle design quality.


This position can be located in Rochester NY, Raritan NJ, or Pencoed Wales.



The Responsibilities

  • Provides Design Control/ Design Change Control Guidance to product development teams including risk management and support of regulatory strategies and plans. 
  • Ensure effective partnering and collaboration with R&D, Quality Operations peers, Regulatory and Operations to meet project goals, maintain compliance, and complete defined regulatory submissions.  
  • Ensures effective implementation of risk management requirements to prevent unanticipated failure modes and quality issues. 
  • Works with limited management oversight and sets an example in ensuring compliance to Design Controls and other Quality System requirements to assigned project(s). 
  • Ensure that DQ, Design Transfer processes, standards, tools and techniques effectively and efficiently meet external standards. Lead process improvements.
  • Collaborates with other QRC groups, R&D and Operations to ensure successful Regulatory Inspections.
  • QA oversight for R&D process related NC/ RCI/ CAPA.


The Individual

  • BA/BS is required (specifically in Life Sciences, Engineering, or Physical Science is preferred).  MA/MS in Life Sciences, Engineering, or Physical Science is preferred.  
  • At least 6 years of related experience in Medical Device quality system management, including Design Control is preferred.
  • Desirable certifications include ASQ –CQA, ASQ-CQE, ASQ-SWQE, ASQ-CQM, Process Excellence; Computer skills/data analysis skills (Word, Excel, Powerpoint, Minitab, Visio, and MS Project) required.  Effective oral & written communication skills required.  External Development Service Providers:  Define accountabilities between companies for Design Control elements on a project by project basis; monitor QA activities and project deliverables for adherence to regulatory requirements.  Suppliers/External Manufacturers: Directly or indirectly support design change control activities.
  • This role may require up to 25% domestic and international travel.
  • 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.


Supplemental Poster


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