Quality Engineer, US Medical Device CLS Q&C
Location:
Bridgewater , Massachusetts
Posted:
February 08, 2017
Reference:
0316161110-en-us

Description

Johnson & Johnson Health Care Systems Inc. (HCS) is currently recruiting for a Quality Engineer, US Medical Device CLS Q&C, to be located in Bridgewater, MA.

 

Johnson & Johnson Health Care Systems Inc. provides account management and customer support services to key health care customers, including hospital systems and group purchasing organizations, leading health plans, pharmacy benefit managers, and government health care institutions. The company also provides contract management, logistics and supply chain functions for the major Johnson & Johnson franchises.

 

Johnson & Johnson Customer & Logistics Services (CLS) is a global Supply Chain organization that supports operating units across all of the Johnson & Johnson Family of Companies.  CLS strives to deliver an exceptional customer experience through leading critical customer facing-functions such as distribution and transportation. In addition, CLS oversees critical business enablers, including how we gather and manage supply chain master data, safe and secure supply chain practices, product identification standards, and market/channel access capabilities. CLS supports all three sectors of Johnson & Johnson: Medical Device & Diagnostics, Pharmaceutical, and Consumer Products.  This team is represented in multiple countries, and continues to grow globally in both visibility and responsibility.   The CLS team reports to Johnson & Johnson Supply Chain and partners closely with groups throughout the supply chain organization.

 

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.

 

Job Overview:


  • ·         Serve as a single point of contact to CLS Quality and Compliance, CLS Operations, CLS 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.
  • ·         Define, implement, and validate quality requirements and systems in alignment with departmental strategies and serve as the business expert on Quality Engineering for US Medical Device Distribution Centers.
  • ·         In collaboration with key business partners, identify opportunities to continuously improve quality, cost and time factors, consistent with both Sector and CLS business objectives. Identifies significant business issues, prioritize for action, and leads improvement opportunities and problem solutions.
  • ·         Establish and validate improvements to systems and process that support: Warehouse Management Systems (SAP/JED), Quality Management Systems and Software systems; CAPA, Non-conformance, Change Control, Document Management, Training, Metrics Reporting, Trending and Statistics, Calibration, Preventive Maintenance and Audit (internal and external) process.
  • ·         Development and implementation of cold chain and temperature controlled ambient solutions and validation protocols in distribution and transportation.
  • ·         Participate in and lead investigations, remediation activities, standards development and implementation, audit and training, identifying preventive opportunities to continuously improve quality, cost and time factors and understanding current and emerging regulations and their impact to quality distribution practices. 

The Quality Engineer, US Medical Device Customer Logistics & Services Quality & Compliance (CLS Q&C) supports strategy development for the CLS US Medical Device Distribution network. This individual will be accountable for:

 

·         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.

 

This position reports to the CLS Quality & Compliance Manager, and has dotted line responsibilities to other CLS Quality & Compliance Managers in the CLS Q&C US MD Network.

 

Responsibilities:


Qualifications

Qualifications: 
Bachelor's degree in engineering, scientific, technical scientific, or Quality Regulatory Compliance disciplines is required.
Minimum of 2 years related experience required, with a minimum of 1 year of regulated healthcare industry experience in distribution, transportation, temperature control, operations, regulatory and/or quality compliance is required.
Prior experience in an engineering role and experience working with an indirect (matrixed) organization that delivers results is required.
Basic understanding of the linkages in quality and regulatory compliance from product development through manufacturing and delivery to customer and health authority is required.
Builds consensus, can lead individuals through change and has strong project management experience is required.
Experience utilizing strong problem solving, decision-making, and root cause analysis skills.
Six Sigma, Lean, 5S or ASQ Certification and trainings are an asset.
Must have excellent communication skills, and strong collaboration and influence skills to partner effectively across functions and operating units.
Makes the complex clear and easily understood by others.
Possess flexibility to work independently and on teams and utilize excellent time management skills to handle multiple projects and deadlines.
Strong knowledge of FDA 21 CFR Part 210, 211 and 820 and ISO 13485 and SAP, ERP systems are requirements. 
Proactive approach to business is preferred.
This position is located in Bridgewater, MA and may require up to 35% regional travel.


BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.



Primary Location
United States-Massachusetts-Bridgewater
Organization
Johnson & Johnson HCS Inc. (6077)
Job Function
Quality (Eng)

A little about us:
Johnson & Johnson cares for the world - bringing innovative ideas, products and services to advance the health and well-being of people.

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