US
0 suggestions are available, use up and down arrow to navigate them
You’re being taken to an external site to apply.
Enter your email below to receive job recommendations for similar positions.
Quality Engineer
GE HealthCare
Noblesville, IN (Onsite)
Full-Time
**Job Description Summary**
As a Quality Engineer, you will be responsible for providing manufacturing and engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and/or service.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Job Description**
**Key Responsibilities**
+ Assists in ensuring quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
+ Leads, develops, communicates and implements strategies to ensure compliance.
+ Supports product and process improvement using a variety of Quality and Continuous Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, DOE, Gauge R&R, etc.
+ Leads the corrective and preventive actions program (CAPA) through use of structured problem solving for effective solutions to non-conformance and remediation action plans.
+ Leads process effectiveness through the development and monitoring of process and equipment verification and validation plans.
+ Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, etc.
+ Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
+ Manages key Quality metrics and maintains associated trending. Identify and drives initiatives to improve Product Quality.
+ Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
+ Communicate within all levels of the organization around QMS concepts.
+ Perform internal audits and participating in external audits.
+ Collaborate, negotiate and work through conflict resolution.
**Qualifications**
+ Bachelor's Degree or a minimum of 6 years work experience, or a Master and 1 year of experience working in a regulated industry.
+ Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
**Preferred Qualifications**
+ Minimum of 3 years' experience in a regulated industry is preferred.
+ Demonstrated understanding ofMedical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
+ Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
+ Demonstrate experience with strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).
+ Global regulatory experience & demonstrated experience interfacing with regulators.
We expect all employees to live and breathe our behaviors, to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
\#LI-KM4
While GE Healthcare does not currently require U.S. employees to be vaccinated against COVID-19, some GE Healthcare customers have vaccination mandates that may apply to certain GE Healthcare employees.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer ([ Link removed ] - Click here to apply to Quality Engineer . 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.
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 (as applicable).
**Relocation Assistance Provided:** Yes
As a Quality Engineer, you will be responsible for providing manufacturing and engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of design, design transfer, manufacturing, distribution, and/or service.
GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
**Job Description**
**Key Responsibilities**
+ Assists in ensuring quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
+ Leads, develops, communicates and implements strategies to ensure compliance.
+ Supports product and process improvement using a variety of Quality and Continuous Improvement tools, including but not limited to Six Sigma, Lean Manufacturing, 5S, SPC, DOE, Gauge R&R, etc.
+ Leads the corrective and preventive actions program (CAPA) through use of structured problem solving for effective solutions to non-conformance and remediation action plans.
+ Leads process effectiveness through the development and monitoring of process and equipment verification and validation plans.
+ Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, etc.
+ Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
+ Manages key Quality metrics and maintains associated trending. Identify and drives initiatives to improve Product Quality.
+ Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
+ Communicate within all levels of the organization around QMS concepts.
+ Perform internal audits and participating in external audits.
+ Collaborate, negotiate and work through conflict resolution.
**Qualifications**
+ Bachelor's Degree or a minimum of 6 years work experience, or a Master and 1 year of experience working in a regulated industry.
+ Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
**Preferred Qualifications**
+ Minimum of 3 years' experience in a regulated industry is preferred.
+ Demonstrated understanding ofMedical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
+ Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment.
+ Demonstrate experience with strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures).
+ Global regulatory experience & demonstrated experience interfacing with regulators.
We expect all employees to live and breathe our behaviors, to act with humility and build trust, lead with transparency, deliver with focus, and drive ownership - always unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
\#LI-KM4
While GE Healthcare does not currently require U.S. employees to be vaccinated against COVID-19, some GE Healthcare customers have vaccination mandates that may apply to certain GE Healthcare employees.
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer ([ Link removed ] - Click here to apply to Quality Engineer . 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.
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 (as applicable).
**Relocation Assistance Provided:** Yes
Recommended Skills
- Auditing
- Business Process Improvement
- Change Control
- Conflict Resolution
- Control Methods
- Database Application
Help us improve CareerBuilder by providing feedback about this job:
Job ID: 2431553232
CareerBuilder TIP
For your privacy and protection, when applying to a job online, never give your social security number to a prospective employer, provide credit card or bank account information, or perform any sort of monetary transaction. Learn more.
By applying to a job using CareerBuilder you are agreeing to comply with and be subject to the CareerBuilder Terms and Conditions for use of our website. To use our website, you must agree with the Terms and Conditions and both meet and comply with their provisions.