Quality Engineer

Job description

3041543
City

Logan
Career Level

Experienced
Relocation Assistance

No
Business

GE Healthcare
Business Segment

Healthcare Global Supply Chain
Function

Manufacturing
Country/Territory

United States
U.S. State, China or Canada Provinces

Utah
Postal Code

84321
Role Summary/Purpose

Responsible for coordination and execution of validation studies in accordance with current Good Manufacturing Practices.
Essential Responsibilities

 Lead analysis of defect data and CAPA creation / resolution and maintain records as specified by the GEHC quality system
 Interface with Supplier Quality on supplier related defects
 Write and conduct validations (IQ/OQ/PQ) for manufacturing processes and equipment
 Maintain regular contact with customers to ensure products meet expectations
 Conduct root cause analysis on product quality issues, identify trends, and communicate with other functional departments for resolution.
 Reduction of MRB and non-conforming material inventory
 Develop, establish, and optimize quality inspection methods, test methods, and product specifications
Ensure compliance through validation and verification (V&V)

Quality Specific Goals:
• Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
• Complete all planned Quality & Compliance training within the defined deadlines
• Identify and report any quality or compliance concerns and take immediate corrective action as required
• Knowledge and understanding of production process work instructions and operates within them to ensure that a device conforms to its specifications
• Ensures the creation of accurate, complete and timely records and DHRs
Qualifications/Requirements

• Bachelors Degree in engineering or science related field or at least 10 years of related industry experience.
• Strong working knowledge of FDA Quality Systems Regulations (21CFR820) (21CFR210) and International Quality System Standards (ISO13485)
• Strong communication skills, verbal and written
• Working knowledge of Excel, Word, Power Point, Minitab, Statistica
• Ability to read and understand CAD drawings
• Some traveling may be required (less than 10% of time)
Desired Characteristics

• 3 years of quality assurance or quality engineering experience
• Green Belt Certified
• CQE Certification
• Lean manufacturing experience
• Strong working knowledge of Current Good Manufacturing Practices (cGMP)
• Demonstrated ability to lead
• Process management skills
• Prior GE Healthcare experience
About Us

GE is the world’s Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is anEqual Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen.