Senior Quality Systems Specialist (1 of 4)
Location:
Wayne , Pennsylvania
Posted:
March 17, 2017
Reference:
5689170109-en-us

The Johnson & Johnson Family of Diabetes Solutions Companies is recruiting Senior Quality Systems Specialist 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 JJDSC 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 Senior Quality Systems Specialist is responsible for the execution of Global Quality Systems process and procedures for the WW Quality System group to include, but not limited to: CAPA / NC / D&DC / Training / Management Review / External Standards / Recall Co-ordination & Records Management ensuring focus on meeting Regulatory, compliance and customer requirements.
 
Responsibilities:
  • Act as an EtQ administrative support SME for NC / CAPA.
  • Act as a Change Management SME in support of CR's to be processed and other D&DC administrative functions.
  • Act as a Training LMS SME to ensure the requirements of the Training Management process are being adhered to.
  • Scheduling, coordinating, execution of Monthly Management Review.
  • Providing input into Quarterly and Bi-annual Management Review.
  • Ensuring procedural alignment to FDA / ISO regulations and JNJ standards.
  • Overall maintenance of the Quality Systems Scorecards.
  • External and JNJ standards - manage the process for ensuring gap assessment completion and assignment of owners for changes to the Quality System.
  • Recall coordination, act as the SME to execute the tactical elements of a recall.
  • Act as a site Records co-coordinator in liaison with the Franchise Records Manager, to ensure the site is in compliance with the requirements of the WWRIM program.
     
    Other Duties:
  • Administrate electronic systems that support applicable quality systems. 
  • Provide ongoing advice, guidance and support to customers on the process and the use of the supporting Software.
  • Troubleshoot and escalate issues as required.
  • Perform periodic routine checks to verify appropriate application.
  • Verify that quality systems are effectively deployed.
  • Collect and compile quality data for reports, perform follow up actions and metrics.
  • Assist in determining root causes of quality issues and develop corrective actions and recommendations.
  • Suggest process and software changes when appropriate.
  • Participate on cross department project teams and in quality system improvement initiatives, owning actions and deliverables.
  • Assist with internal and external audits, generate reports with corrective action plans and ensure implementation of corrective actions in a timely fashion.
 
Internal Contacts:
  • Cross functional leadership within CMD to ensure alignment of transition plans, report on progress and to ensure alignment of resources to achieve stated objectives.
  • Quality leadership at Enterprise to provide project alignment and progress in accordance with established timelines.
 
External Contacts:
  • Notified Body representatives to communicate migration strategy, timing and progress as required to align with established timelines to achieve verified conformance with EU MDR.

Qualifications
Requirements:
  • University/Bachelor’s Degree or Equivalent.
  • Five or more years of experience in Compliance, Quality Systems or Quality Assurance within a Medical Devices and Diagnostics and other regulated, healthcare industries is required. 
  • Knowledge of FDA Quality System Regulations and ISO 13485 Standard is required. 
  • Experience with multiple, global quality systems such as Audits, CAPA, Non-Conformance, Change Control, Design Controls and Document and Data Control, Training and Records Management to include the use of process excellent methodologies for new initiatives and process/system improvements.
  • Proficiency in using software systems.
  • Ability to analyze and make decisions based on data gathered.
  • Experience leading global, cross functional projects.
  • Experience writing and revising procedural documents.
  • Ability to multi task and define priorities.
  • Experience with problem solving/reasoning abilities.
  • Troubleshooting skills/root cause investigation.
  • Ability to effectively communicate (orally or via written communication) changes, updates, process improvements to the business partners or members of the organization.
  • Experience implementing and deploying new processes and systems.
  • Create and present presentations.
  • Experience creating agendas, writing minutes and follow up actions.

Primary Location
United States-Pennsylvania-Wayne
Organization
Lifescan Inc. (6097)
Job Function
Quality Systems

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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