SENIOR LCM & QA SYSTEM ENGINEER Job in Raritan, New Jersey Us
Ortho Clinical Diagnostics, a member of Johnson Johnson's Family of Companies, is recruiting for a Senior Lifecycle Management Quality System Engineer, located in Raritan, New Jersey or Rochester, New York.
Ortho Clinical Diagnostics (OCD), a Johnson Johnson company, provides high-quality in vitro medical testing products that help people recover and maintain health throughout the world. Our vision is: enabling people to be healthier feel better and live longer. Our products include reagents and instruments systems used in blood typing and donor testing; clinical chemistry determinations and immunoassays for disease diagnosis and therapy management, as well as RhoGAM, an injectable drug used to prevent hemolytic disease of the newborn.
The Senior Lifecycle Management Quality System Engineer leads and provides support for the development, execution and delivery of quality strategies for the entire lifecycle of the OCD Franchise portfolio from initiation to retirement, including design, manufacture and post-launch. The person in this role interfaces with the Franchise Quality Regulatory and Compliance (QRC) and MDD Sector organizations for the development, execution and delivery of quality strategies for the lifecycle of the OCD portfolio from initiation to retirement, including design, manufacture and post-launch. The individual partners with QRC, Operations, Regulatory Affairs, Sector Quality Operations and Safety, Risk Management and Surveillance departments to assure the Franchise quality and compliance deliverables and metrics are established, collected and reported as needed to support the growth of the Franchise global business. The Senior Lifecycle Management and Quality System Engineer leads and supports key projects and initiatives for OCD to standardize and harmonize quality systems to align with the MDD and the JJ Enterprise strategies, and represents OCD on various MDD initiatives to provide the Franchise perspective and improve processes and the quality system. He or she leads the team through changes and enables deployment of process improvements while also working with the WW Director LCM and Franchise QS to support escalation of issues between the Franchise, Sector and Enterprise as required.
The Senior Lifecycle Management Quality System Engineer supports the preparation of the Franchise level Management Review when needed by working with OCD sites and Management to ensure that the proper inputs from Supply Chain are included. The individual provides Quality Engineering support and oversight to assure there is appropriate execution of design controls, process validation, and process development for new products, supplier development and failure investigation. The person in this position is responsible for complying with company policies and procedures and decisions may impact regulatory compliance status, customer satisfaction, and the ability to meet current and long-term strategic business goals. Erroneous decisions or recommendations could normally result in increased compliance exposure, customer dissatisfaction, significant delays or modifications causing substantial increased costs and time.
The Senior Lifecycle Management Quality System Engineer interfaces with multiple functions within the Franchise including Compliance, Franchise Operations Development, Regulatory Affairs, New Product Innovation/Design Quality, Research Development, and the MDD Supply Chain. The Senior Lifecycle Management Quality System Engineer must be able to multi-task and change priorities quickly while maintaining focus.
Qualifications
A Bachelor's degree and a minimum of 4 years of related experience, or an Advanced degree and a minimum of 2 years of related experience is required. Strong communication, organization, and planning skills, plus the ability to think critically and strategically is required. Proficiency in the Microsoft Office suite of products is required. The ability to work cross-functionally in a matrix environment is required. Up to 20% international and domestic travel may be required. This position can be located in Raritan, New Jersey or Rochester, New York.
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