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. 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, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Role Summary: This position provides process support in accordance with documented procedures & practices. He/she develops the strategy to meet compliance requirements and is responsible for the creation and application of software development practices, guidelines and standards for development of medical device software across the product life cycle, with focus on QA practices & proactive quality improvement. The role will involve work in software design, fulfillment, and service.
1. Utilizes and shapes the quality process, tools and aids for use by the organization in accordance with documented procedures, including but not limited to agile methods, automated testing and code analysis, continuous integration, relaibility analysis, FMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops plans and strategies that are designed to mitigate the quality risks
2. Provide guidance to product teams to ensure quality and compliance throughout product life cycle including product definition, design, customer fulfillment and service
3. Identifies and influences continuous product and process improvement through detailed cost of quality analysis: investigate, develop and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
4. Leads quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
5. Develops, implements, and continuously improves process effectiveness and efficiency,
6. Interface with leadership and influence and lead various initiatives on a global level.
7. Leverages metrics to assist in shaping the strategy of the assigned area of responsibility.
8. The Senior QA Engineer coaches junior QA Engineers.
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.
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 required
Desired Characteristics: 1. Desired: Master's Degree or PhD in Engineering or Technical Discipline.
2. Quality Assurance/Quality Engineering experience in the medical device or pharmaceutical industry or experience in design engineering or manufacturing engineering in the medical device field.
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.
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 and 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 regulators.
15. Demonstrated understanding or aptitude to understand IEC 62304
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