Johnson & Johnson Careers

Quality Engineer, Deliver & Distribution

Warsaw, Indiana
Quality (Eng)


Job Description

Requisition ID: 6954190208

Johnson & Johnson is currently hiring a Quality Engineer in Warsaw, IN.


Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly-based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.


The Quality Engineer supports strategy development for the Deliver US Medical Device Distribution network. They will be accountable for the development, oversight and execution of quality and compliance engineering and validation programs, facility and technology transfers and integration/divestitures to meet customer and business needs in compliance with regulatory requirements, Enterprise Standards, Quality Management Systems at Medical Device Distribution Centers in the United States.


Duties:

• Single point of contact to Deliver Quality and Compliance, Deliver Operations, Deliver Engineering, Information Technology (IT), Centers of Excellence (COE’s) and Project Management Organization (PMO’s) in the US on Distribution and Transportation Quality Engineering related matters and liaise with multiple Quality organizations to drive timely resolution of Quality related issues associated with Distribution.

• Defines, implements, and validates quality requirements and systems in alignment with departmental strategies and serves as the business expert on Quality Engineering for US Medical Device Distribution Centers.

• In collaboration with key business partners, will find opportunities to continuously improve quality, cost and time factors, consistent with both Sector and Deliver business objectives. Identifies significant business issues, prioritize for action, and leads improvement opportunities and problem solutions.

• The development and implementation of cold chain and temperature controlled ambient solutions and validation protocols in distribution and transportation.

• Participating and leading investigations

• Remediation activities

• Standards development and implementation

• Audit and training

• Identifying preventive opportunities to continuously improve quality, cost and time factors

• Understanding current and emerging regulations and their impact to quality distribution practices.

• Responsible for establishing and validating improvements to systems and process that support:

            o Warehouse Management Systems (PRMS/SAP)

            o Quality Management Systems and Software system;

            o CAPA’s

            o Non-conformance

            o Change Control

            o Document Management

            o Training

            o Metrics Reporting

            o Trending and Statistics

            o Calibration

            o Preventive Maintenance and Audit (internal and external) process


Qualifications
• Bachelor's degree in engineering, scientific, technical scientific, or Quality Regulatory Compliance disciplines is required.
• Minimum of 1 year of regulated healthcare industry experience in distribution, transportation, temperature control, operations, regulatory and/or quality compliance is required.
• Experience in an engineering role and experience working with an indirect organization that delivers results is required.
• Understanding of quality & regulatory compliance from product development through manufacturing, delivery to customer and health authorities is required.
• Strong problem solving, decision-making, and root cause analysis skills is required
• Approximately 20-35% travel within region is required.
• Builds consensus, can lead individuals through change and has strong project management experience is preferred
• Six Sigma, Lean, 5S or ASQ Certification and trainings is preferred
• Excellent communication skills, strong collaborative & influencing skills to partner effectively across functions and operating units is preferred
• Flexible with ability to work independently and on teams and has excellent time management skills to handle multiple projects and deadlines is preferred
• Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and ISO 13485 and SAP, ERP systems are preferred
• Dedicated approach to business is preferred.
• The primary location for this position will be Warsaw, IN

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.


Primary Location
United States-Indiana-Warsaw-
Organization
Johnson & Johnson HCS Inc. (6077)
Job Function
Quality (Eng)
Requisition ID
6954190208