Staff Quality Systems Engineer
Location:
Cincinnati , Ohio
Posted:
January 08, 2017
Reference:
000017M0/2-en-us

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.

Responsibilities include:
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. 

BE VITAL in your career, Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.

J2W: LI NA


Primary Location
United States-New Jersey-Somerville
Other Locations
North America-United States-Ohio-Cincinnati
Organization
Ethicon Inc. (6045)
Job Function
Quality Systems

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