Quality Assurance Engineer

4 weeks ago


Raritan, New Jersey, United States Disability Solutions Full time
Job Summary

The Quality Assurance Engineer will play a key role in ensuring the highest quality experiences for our patients and customers. This position will be responsible for supporting Quality Engineering activities related to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) or the Biosurgery Platforms. WCH is a market leader in surgical tissue healing with a broad portfolio including Antibacterial sutures, Knotless Tissue Control Devices, Topical Skin Adhesives, Skin Closure Systems, and traditional absorbable and non-absorbable surgical sutures with innovative needle technologies. The Biosurgery Platform consists of a comprehensive portfolio of adjunctive hemostats and sealants.

Duties & Responsibilities

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson& Johnson, procedures and guidelines, this position:
  1. Learns the details of medical device risk management and performs Application & Design Failure Mode and Effect Analysis for existing and new products. Furthermore, contributes towards the improvement of the combination products program in compliance with 21CFR part 4 (FDA Regulation for combination products).
  2. Assists in various lifecycle management activities including product design changes, complaint trending and analysis, assessment of quality signals, CAPA and remediation activities, and integration of regulations, such as the EU MDR, into the business.
  3. Supports the Franchise Technical training program and works to expand it to manufacturing sites. This involves ensuring a robust pipeline of training offerings, managing schedules across time zones, distributing training materials, maintaining digital communications channels, and supporting the Subject Experts with developing content and facilitating their training sessions.
  4. Helps plan and execute team building events.
  5. Responsible for communicating business-related issues or opportunities to next management level.
  6. Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
  7. For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
  8. Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
  9. Performs other duties assigned as needed.


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Quality Assurance SupervisorLegend Biotech US is seeking a Quality Assurance Supervisor to provide quality oversight over the production of a personalized cell therapy in a sterile GMP environment. The successful candidate will have a minimum of 5 years of relevant work experience and a Bachelor's Degree in Science, Engineering, or equivalent technical...


  • Raritan, New Jersey, United States Johnson & Johnson Full time

    Job SummaryThe Quality Engineer Co-Op will support Quality Engineering activities related to Design Controls, Product & Process Validation, Risk Management, and Lifecycle Management for the Wound Closure and Healing (WCH) or the Biosurgery Platforms. This role will be responsible for learning medical device risk management and performing Application & Design...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryWe are seeking a highly skilled Cell Therapy Quality Assurance Specialist to join our Quality team based in Raritan, NJ.The successful candidate will be responsible for performing quality control testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job Title: QA Document Control LeadLegend Biotech US is seeking a highly skilled QA Document Control Lead to join our Quality team based in Rarita, NJ.Job Summary:The QA Document Control Lead will be responsible for supporting the document management process within a cell therapy manufacturing facility to meet both clinical and commercial requirements in a...


  • Raritan, New Jersey, United States Johnson and Johnson Full time

    Job SummaryJohnson & Johnson is seeking a Senior Manager of Quality Management Systems to oversee the operations of the company's Technology Services QMS. This role will be responsible for ensuring the highest standards of quality and compliance, and will work closely with the Director of the QMS to establish and maintain quality assurance standards.Key...


  • Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Summary: We are seeking a highly skilled Senior Quality Systems Specialist to join our team at Janssen Pharmaceuticals, Inc., a member of the J&J Family of Companies. The successful candidate will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions.Key Responsibilities:Perform Quality...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryThe Quality Compliance Lead will be responsible for ensuring regulatory compliance in the production of autologous CAR-T products for clinical trials and commercial operations in a controlled cGMP cleanroom environment. This role will support the implementation, execution, and improvement of the internal audit process, as well as coordinate front...


  • Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Title: Senior Specialist, Quality SystemsJob Summary:We are seeking a highly skilled Senior Specialist, Quality Systems to join our team at J&J Family of Companies. As a Senior Specialist, Quality Systems, you will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions. You will assess...


  • Raritan, New Jersey, United States Johnson and Johnson Full time

    We are seeking a highly skilled Quality Systems Specialist to join our team at Johnson & Johnson. In this role, you will independently perform Quality Systems activities, identify issues, and implement resolutions, assess data, and independently prepare and review documentation.Key Responsibilities:Provide support and robust guidance for Quality Systems,...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job Title: Quality Compliance LeadLegend Biotech US is seeking a Quality Compliance Lead to join our Quality team based in Raritan, NJ.Job SummaryThe Quality Compliance Lead will be responsible for regulatory compliance supporting the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom...


  • Raritan, New Jersey, United States J&J Family of Companies Full time

    Job Summary:We are seeking a highly skilled Senior Quality Systems Specialist to join our team at J&J Family of Companies. As a key member of our Quality Systems team, you will be responsible for independently performing Quality Systems activities, identifying issues, and implementing resolutions. You will assess data and prepare and review documentation to...

  • QC Supervisor

    4 weeks ago


    Raritan, New Jersey, United States Legend Biotech US Full time

    Job DescriptionLegend Biotech US is seeking a highly skilled QC Supervisor to join our Quality Operations team. As a key member of our team, you will be responsible for supervising the operation and workflow of the quality control laboratories in support of cell therapy manufacturing.Key ResponsibilitiesTraining and Development: Ensure adequate training of...


  • Raritan, New Jersey, United States Johnson and Johnson Full time

    Johnson & Johnson is seeking a Senior Manager of Quality Management Systems to oversee the operations of the company's Technology Services QMS. This role will be responsible for ensuring the quality system is flawless, world-class, and adheres to GxP requirements and ISO regulations.The ideal candidate will have 8-10 years of progressive experience in the...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job DescriptionLegend Biotech US is a global biotechnology company dedicated to treating and curing life-threatening diseases. Our mission is to advance the promise of immunotherapy in the treatment of multiple myeloma.Job SummaryWe are seeking a highly skilled Quality Control Specialist to join our team based in Raritan, NJ. The successful candidate will be...


  • Raritan, New Jersey, United States The Dignify Solutions LLC Full time

    Key Responsibilities:As a Snowflake Data Engineer at The Dignify Solutions LLC, you will be responsible for designing and implementing complex data transformations in Snowflake using DBT. You will work closely with our team to develop and maintain our data warehouse and ensure data quality and integrity.Requirements:* 5+ years of experience in IT with a...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryWe are seeking a highly skilled Cell Therapy QA Specialist to join our Quality Operations team based in Raritan, New Jersey.Key ResponsibilitiesProvide quality oversight of all aspects of the cell therapy clinical manufacturing process.Supervise manufacturing and manufacturing support activities for cGMP compliance through spot checks/internal...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryLegend Biotech US is seeking a highly skilled Quality Control Specialist to join our team in Raritan, NJ. As a key member of our Quality team, you will be responsible for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.Key...

  • Software Engineer

    4 weeks ago


    Raritan, New Jersey, United States Johnson and Johnson Full time

    Job SummaryWe are seeking a highly skilled Principal Engineer to join our team at Johnson & Johnson. As a domain expert in DevOps tools and strategy, you will design and develop industry-leading platforms and solutions that enable software development across the enterprise.The successful candidate will have a strong understanding of end-to-end software...


  • Raritan, New Jersey, United States Johnson & Johnson Full time

    Job Title: Senior Manager, Construction Safety AmericasJohnson & Johnson is seeking a highly skilled Senior Manager, Construction Safety Americas to join our team. As a key member of our Engineering & Property Services (E&PS) team, you will be responsible for deploying comprehensive construction safety standard methodologies and tactics to ensure safe work...


  • Raritan, New Jersey, United States Legend Biotech US Full time

    Job SummaryThe Investigator will be part of the Technical Operations team and will be responsible for the investigations of Operations QIs to determine applicable corrective and preventive actions in accordance with our company regulations and other global health authority regulators such as FDA. The Investigator will collaborate cross functionally to close...