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Quality Engineer II
Ref No.: 18-08715
Location: Cincinnati, Ohio
Start Date / End Date: 06/18/2018 to 12/18/2018


Job Title: Quality Engineer II
Duration: 6 months
Location: Cincinnati, OH- 45242

Job Description:
 
  • Own the collection, creation, and presentation of periodic reports & presentations related to product risk escalations and field action processes for both the CSS and Ethicon business platforms.
  • Develop strategies and capabilities to harmonize metrics and data reporting between the CSS and Ethicon business platforms.
  • Support the investigation and documentation of product risk assessments and Field Action activities when needed.
  • Support process improvement activities related to the product risk escalation and field action processes.
 
Job Qualifications:
 
  • A minimum of a Bachelor's degree is required, preferably in a medical, technical or related field of focus.
  • Experience in a medical device, pharmaceutical or FDA regulated industry is preferred.
  • Experience in data analytics and associated reporting is preferred.
  • Prior knowledge of ISO and/or cGMP regulations is preferred.
  • Basic knowledge in Statistics, Sampling Planning, Risk Assessment and Process Validation is preferred.
  • Ability to communicate effectively with all levels within Quality as well as cross functionally is required.
  • Prior knowledge of quality system processes (CAPA, complaints, non-conformity) is preferred.
  • Strong organizational skills, time management skills and ability to self-manage in a complex/ time sensitive environment is required.
  • Prior experience effectively working through periods of change, ambiguity and complexity is required
  • Experience thriving in a collaborate work environment is required.
  • This position is located in Cincinnati, OH and travel is not anticipated for this role.


Apply on-line for immediate consideration, please send your updated resume and contact info via
 Contact: Rashmi M
Email: rashmi@sunrisesys.com | Phone: 732 272 0331