Customer Quality Engineer
Location:
Wayne , Pennsylvania
Posted:
April 02, 2017
Reference:
1598170329-en-us

The Johnson & Johnson Family of Diabetes Solutions Companies is recruiting for a Customer Quality Engineer to be located in Wayne, PA.
 
The Johnson & Johnson Diabetes Care Companies (JJDCC) includes blood glucose monitoring systems (LifeScan, Inc.), insulin delivery systems (Animas Corporation and Calibra Medical) and healthcare professional product training and educational programs to improve care and outcomes (The Johnson & Johnson Diabetes Institute).
 
The JJDCC are committed to creating a world without limits for people with diabetes by offering innovative products and services to best serve their needs.  The JJDCC culture is founded on the principles of the Johnson & Johnson Credo, Johnson & Johnson Leadership Imperatives and three JJDCC values: We Care About Everything We Do; We Execute with Excellence and Keep Our Promises; and We Compete as One.  
 
To find out more, visit www.Animas.com  OR www.LifeScan.com.
 
The Customer Quality Engineer responsibilities include:
  • Responsible for the execution of the Diabetes Care Franchise (DCF) Complaint Management process as assigned by product or region:  complaint capture, investigation, trending and reporting, escalation, timeliness, and customer insights.
  • Responsible to support complaint handling systems, software, and report applications: identify and correct systems issues and reports, and identify and improve systems and processes. 
  • Troubleshoot and correct issues identified through DCF Quality Systems.
  • Identify unique or unusual issues or trends, present in appropriate forums, and escalate through DCF Quality Systems.
  • Execute transactional tasks to support the complaint management process (DHR review and scanning, data collection/correction/upload, CAPA/FIR linkage etc…).
  • Investigate complaints, trends, and target/threshold breaches for periodic reporting and ad hoc requests (CAPA, Issue Escalation, etc…)
  • Where appropriate, conduct Failure Investigations and assist in the processes for submission of Medical Device Reports and Alternate Summary Reports.
  • Create reports and present information in appropriate forums (Post Launch Issues Monitoring, Management Review, CAPA Governance etc…)
  • Escalate identified issues per DCF Quality Systems and Procedures.
  • Identify opportunities for improvement to drive timeliness / accuracy metrics in the complaint management process and linked processes.
  • Identify and communicate product or regional customer insights that will enable marketing / sales / research and development and other business partners to improve design inputs.  Provide these insights for both complaint and non-complaint customer contacts.
  • All other duties as assigned.
  • Lead activities to design/implement improvements to drive timeliness / accuracy metrics in complaint management processes and linked processes.
  • Collaborate with other departments to lead or support change / improvement efforts (Customer Support, Product Analysis, Medical Surveillance, Research and Development, Marketing / Sales).
  • Represent Customer Quality on new product launch teams and significant initiatives.  Act as primary contact responsible for ensuring customer and product insights are understood and available to the various stewardship, sponsor, and other development teams.
  • Lead and/or facilitate prioritization activities resulting from customer / product insights.
  • Identify, raise, and escalate G-Tracks to support IT improvements to the complaint management systems.
  • Provide technical systems knowledge to team and act as trainer where required on systems capabilities.
  • Provide on-boarding and coaching of co-ops and temporary resources.

Qualifications
Requirements:
  • A minimum of a Bachelor’s Degree, preferably in a medical or engineering field with an emphasis on statistics and trend analysis. 
  • 2-4+ years of Medical Device or Pharmaceutical industry experience required; complaint management, post market vigilance, risk management, or compliance experience preferred
  • Green Belt (Six Sigma) or other formal Investigation Training; Black Belt (Six Sigma) or CQE (ASQ) certification or equivalent preferred.
  • Experience with MS Office, Minitab, Siebel, and SAS preferred.
  • Ability to work individually as well as on a team.
  • Ability to work an extended period of time on a computer.
  • Ability to communicate effectively verbally and in writing (technical and persuasive)
  • Ability to present to multiple levels and departments within the organization (i.e. local area issue review, post launch issue monitoring, management review)
  • Travel as required (10-25%) to support process improvements and audits.

Primary Location
United States-Pennsylvania-Wayne
Organization
Animas Corporation (6150)
Job Function
Quality (Eng)
Requisition ID
1598170329

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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