about 1 month ago
The Supplier Quality Engineer is responsible for driving exceptional product quality for the patient, customer value beyond expectations, regulatory assurance and optimized Cost of Quality for GEHC. This is a key technical leadership position, affecting part quality for both installed base and New Product Introduction (NPI) parts.
•Improve supplier quality performance for assigned suppliers via Quality Plan implementation
•Approve supplier selection through robust qualification processes
•Assure supplier compliance to GEHC QMS and regulatory requirements through supplier monitoring process
•Develop positive relationships and work closely with Global Sourcing Leaders and Modality Sourcing Leaders to manage and implement supplier/engineering changes, New Product Introductions, and transfers.
•Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize supplier software defects (“bugs”) and Costs of Quality, specifically Failed on Arrival/Install (FOA/FOI) issues, Field Failures and Factory defects.
•Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with Supplier Corrective Action Request (SCAR) process.
•Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance.
1.Bachelors Degree in an engineering or technical discipline (or non-technical degree with 5 years of experience in manufacturing, engineering or quality assurance experience, or an Associate’s Degree with 15 years of manufacturing, engineering or quality assurance experience).
2.Minimum 3 years experience in manufacturing, engineering design, quality assurance or regulatory assurance
3.Proficiency with Microsoft Excel Spreadsheet development and analysis 4.Effective problem solving, root cause analytical skills to lead and influence others to drive change (cross functionally and globally).
1. Minimum 3 years’ experience in manufacturing, design, quality assurance or regulatory assurance with a computer and/or software background desired.
2. ASQ Certified Software Quality Engineer (CSQE) or Certified Quality Auditor (CQA).
3. Prior experience working with regulated software products and suppliers of software products/services.
4. Demonstrated knowledge of regulations pertaining to medical device products such as 21 CFR 820, ISO 13485, and IEC 62304.
5. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes.
6. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production and process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc.
7. Demonstrated collaboration, negotiation, influencing, and conflict resolution skills. 8. Excellent oral communication & report, business correspondence & procedure-writing skills.
GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers.
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.
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 (as applicable).