HireDiversity

Raritan, NJ, US

SENIOR QUALITY ENGINEER-1932121217

Description

Ortho Clinical Diagnostics, a member of Johnson & Johnson's Family of Companies, is recruiting for a Senior Quality Engineer, to be located in Raritan, NJ.

Ortho Clinical Diagnostics serves the transfusion medicine community and laboratories around the world. We're a leading provider of total solutions for screening, diagnosing, monitoring and confirming diseases early, before they put lives at risk. Our single focus is to help hospitals, laboratories and blood centers worldwide deliver results that help patients experience a better quality of life.

The Senior Quality Engineer provides leadership and technical support to Quality & Regulatory Compliance (QRC) and Operations staff on all aspects of the biological manufacturing process controls. Utilizes key Quality Engineering (QE) principles, tools, and practices to develop and optimize systems and processes that are aligned with the overall business and the Quality Policy. Supports manufacturing in addressing quality events related to product release including non-conformance, product disposition, root cause investigation, laboratory OOS, and corrective/preventative action. Assures inspection readiness programs are effectively implemented within the organization. Provides complex product team support for quality system design and audit, compliance assessment, and for support of steady state manufacturing processes. Drives quality related decisions, with appropriate approval authority (both data-based and risk-assessment-based decisions). Utilizes multifaceted industry and process excellence standards on an expert level in daily quality operations, including good manufacturing practices (GMP), equipment engineering system (EES), and international organization for standardization (ISO).

This position will require a strong background in validation, statistical process controls, and regulatory compliance. This individual is responsible for implementing quality assurance programs in the medical device, biologics and parenterals for Transfusion Medicine and Cellular Technologies. Supports equipment and process validation by participating in the development of studies and validation protocols to assess manufacturing capability/reliability. Demonstrates working knowledge of current and applicable GMP regulations e.g.: ISO13485 / 21 CFR Part 820. Demonstrates and utilizes high level knowledge of manufacturing process and detailed knowledge of own work area. Demonstrates knowledge of and ability to implement the CAPA process as per SOPs. Actively supports CAPA to drive improvements.

Qualifications


A Bachelor's degree in Chemistry, Biochemistry, Biology, Chemical Engineering or a related discipline is required. A minimum of 6 years experience in Quality, Regulatory and/or Compliance in a highly regulated manufacturing environment (Diagnostics, Medical Device, Pharmaceutical, or Consumer) is required. Knowledge of current and applicable GMP regulations is required. Knowledge of Quality System Regulations (QSR) and International Organization for Standardization (ISO) regulations required. Must have the ability to make solid risk based decisions that will effectively support the business and company policies. The ability to effectively prioritize and manage multiple project workloads is required. Candidates who possess experience with statistical tools such as SPC, Sampling Plans, Experimental Design and Optimization tools are preferred. Microsoft Office tools experience for communications, reporting, and data analysis is required (Word, Excel, PowerPoint, etc.). Report writing skills are required. This position will require up to approximately 10% domestic travel and will be based in Raritan, NJ.

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Primary Location:North America-United States-New Jersey-Raritan
Organization: OCD Inc. (6118)