U.S. State, China or Canada Provinces
This position is responsible for providing quality management system (QMS) process support in
accordance with documented procedures and practices. This is a key technical role responsible
for the development, implementation, improvement & continuous reinforcement of established
Quality Compliance fundamental practices for the GEHC Digital business. The role also performs internal audits, supports external audits & promotes product & process improvements through root cause analysis & CAPA.
1. Assists in ensuring quality and regulatory compliance in accordance with
documented procedures. 2. Supports site QA in maintaining and improving the site QMS, and maintaining existing site certifications (ike MDSAP, ISO 13485). 3. Responsible for the
development, implementation, and continuous improvement of process effectiveness and
efficiency at the site. 4. Develops process improvement plans using a variety of Quality and
Continuous Process Improvement tools, including but not limited to Six Sigma, Lean
Manufacturing, 5S, SPC, engineering studies, DOE, Gauge R&R, etc. 5. Supports continuous product and process improvement through detailed failure
analysis for non-conformances, and investigates, develops and implements effective and
compliant solutions for product or process corrections, retrospective and remediation action plans,
and for corrective and preventive actions (CAPA Program). 6. 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, Failure Mode Analysis, etc. Supports design
mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate
the risks identified through the Risk Management process. 7. Ensures process compliance through
the development of comprehensive procedures, work instructions, flowcharts, forms, templates,
checklists, worksheets, and other product and process related documentation. 8. Performs a broad variety of tasks in
support of product and process compliance as assigned. 9. Manages internal audit program, and supports external audits.
1. Bachelor's Degree or a minimum of 4 years work experience. 2. Minimum of 1 year experience
working in a regulated industry or a Masters degree 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. Quality Specific Goals: 1.
Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality
Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job
type/position. 2. Complete all planned Quality & Compliance training within the defined deadlines.
3. Identify and report any quality or compliance concerns and take immediate corrective action as
1. Minimum of 3 years experience in a regulated industry is preferred 2. 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. 3. Demonstrated
knowledge of Quality Management System tools, continuous improvement methodologies & in-depth
understanding of site level products & related processes 4. Demonstrated expertise to
effectively communicate within all levels of the organization around concepts of design controls,
design verification and validation activities; production &process controls; Corrective & Preventive
Action (CAPA), complaints & risk management; & product quality improvement using tools such as
six sigma, DFR, etc. 5. Demonstrated collaboration, negotiation & conflict resolution skills 6.
Excellent communication skills (written and oral) 7. Demonstrated ability to lead, acknowledge,
develop, communicate & implement a strategy under crisis situations to ensure compliance 8.
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. 9. Demonstrated
understanding of continuous quality / process improvement tools: (As defined by the local site, e.g.
DMIAC, SPC, Lean SS, 5S) 10. Experience leading and implementing change 11. Experience
performing internal audits and participating in external audits 12. Exceptional analytical, problem
solving & root-cause analysis skills 13. Ability to multi-task & handle tasks with competing priorities
effectively 14. Strong technical aptitude (i.e. able to read & comprehend technical documentation
& execute procedures), global regulatory experience & demonstrated experience interfacing with
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.