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Quality Engineer II
Ref No.: 18-04136
Location: Cincinnati, Ohio
Start Date / End Date: 06/18/2018 to 12/18/2018
• 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.
Hours per Day 8
Hours per Week 40
Total Hours 1,056.00