Ethicon, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Quality Systems Engineer located in Cincinnati, OH or Somerville, NJ.
Ethicon, Inc. is a trusted, world-wide leader in surgical care. For over a century, Ethicon has continuously introduced innovations in wound closure, general surgery, wound management, women's health and urology and aesthetic medicine that fulfill the company's vision: Restoration of Body and of Life.
This role will serve as a Franchise External (Internal / External) Standards Process Owner for enforcing compliance to applicable product, process, and Quality-related standards, including ISO, MDD, GMP, QSR regulations and international standards, as well as internal JNJ Policy, technical, and sector standards. Independently evaluating business relative to GMP (Good Manufacturing Practices), QSR (Quality System Regulation), GLP (Good Laboratory Practices), GCP (Good Clinical Practices. Supporting development and implementation of quality systems designed to ensure continuous production of product consistent with established standards and customer expectations.
• A Maintain Master Standards List, along with other Standards tracking mechanisms consistent with Quality processes
• Collaborate with SMEs to complete Gap Assessments and Implementation Plans to claim compliance with standards
• Lead and Participate in communication channels with SMEs and Management, including Governance councils and status reporting
• Track and Trend monthly and quarterly Standards performance metrics
• Proactively communicate Risk and Mitigations related to Standards
• Support internal and external audits.
• Maintain associated documentation for Standards process
• Perform other job-related duties as assigned.Qualifications
• A Bachelor's degree in a Life Science, Engineering, Physical Science, or a related area of study or equivalent experience. Master’s degree preferred.
• A minimum of 6+ years of related experience within a regulated industry is required.
• Evidence of managing projects which lead to positive, tangible business results. Project Management certification preferred
• Quality Management Software, Trackwise or EPQ Tracking Software Solutions, experience preferred
• Excel, Sharepoint, experience preferred.
• The ability to independently analyze data, identify trends, formulate and implement corrective action to improve overall quality systems compliance, effectiveness, and efficiency will be needed. Ability to analyze, balance, and prioritize risk.
• An ASQ certification (CQE, CQM, CRE or CQA) is an asset. Six Sigma (Green Belt, Black Belt, etc.) or Process Excellence certification is an asset. Prior project management experience is preferred.
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J2W: LI NA
United States-New Jersey-SomervilleOther Locations
North America-United States-Ohio-CincinnatiOrganization
Ethicon Inc. (6045)Job Function