Global Process Risk Manager

General Electric Waukesha , WI 53186

Posted 7 days ago

Global Process Risk Manager

  • GE Healthcare

  • Experienced

  • Posted 3/13/2019 3:57:18 PM

  • 3266072

  • Job Function: Quality

  • Business Segment: Healthcare Quality

Location(s): United States; Alabama, Alaska, American Samoa, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Northern Mariana Islands, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, United States Minor Outlying Islands, Utah, Vermont, Virgin Islands, U.S., Virginia, Washington, West Virginia, Wisconsin, Wyoming; Waukesha

Role Summary:

This position provides process and technical support in accordance with documented procedures & practices for process risk development for GE Healthcare. He/she is responsible for mentoring, coaching and developing standards for implementing process risk analysis across GE Healthcare.

Essential Responsibilities:
1.Leads quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
2.Ensures regulatory compliance and flow down of regulatory requirements into the Quality Management System, specifically related to process risk.
3.Develops, implements, and continuously improves guidance and training for process risk execution (pFMEA, fault tree analysis, etc).
4.Lead actions to prioritize and remediate compliance risk of the Quality System with regards to process risk.
5.Drives strategic alignment with business strategy, implementation and deployment of risk management for processes.
6.Support regulatory inspections as required.
7.Travel as needed to sites to perform training and provide guidance/support.
9. . Interfaces with site leadership on various initiatives.8. Leverages metrics to assist in shaping the strategy of the assigned area of responsibility.

Qualifications/Requirements:
1.Bachelor's Degree or a minimum of 10 years work experience. 2. Minimum of 5 years working in a regulated medical device or pharmaceutical industry. 3. Ability to communicate effectively in English (both written and oral). 4. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications. 5. Experience managing project teams. 6. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics:
1.Desired: Master's Degree or PhD in Engineering or Technical Discipline.
2.Quality Assurance or Reliability Engineering experience in the medical device or pharmaceutical industry or experience in design engineering or manufacturing engineering in the medical device field.
3.Experience creating, developing or executing process risk controls (pFMEA)
4.Demonstrated strength in coaching and mentoring
5.Excellent communication skills (written and oral)
6.Demonstrated ability to drive solutions and think strategically.
7.Exceptional analytical, problem solving & root-cause analysis skills
8.Ability to multi-task & handle tasks with competing priorities effectively
9.Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience with process risk development.
10. Experience working with global teams
11. Experience working on a program team supporting multiple programs/modalities

About Us:

GE Healthcare provides transformational medical

technologies and services to meet the demand for increased access, enhanced quality and more affordable

healthcare around the world. GE works on things that matter - great people and technologies taking on tough

challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,

biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps

medical professionals deliver great healthcare to their patients.

target="_blank">Learn More About Careers at GE

Learn More About GE

Healthcare

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Locations: United States; Alabama, Alaska, American Samoa, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Guam, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Northern Mariana Islands, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, United States Minor Outlying Islands, Utah, Vermont, Virgin Islands, U.S., Virginia, Washington, West Virginia, Wisconsin, Wyoming; Waukesha

GE will only employ those who are legally authorized to work in the United States for this opening.


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