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Sat May 5, 2018 - 28 weeks ago

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Lead - Supplier Quality Engineer

**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 an Equal Opportunity Employer at -000845%20EEO%20combined.pdf . 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:**

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 manufactured pharmaceuticals.

**Essential Responsibilities:**

1. Improve supplier quality performance for assigned suppliers via Quality Plan implementation. 2. Approve supplier selection through GEHC Life Sciences-Core Imaging qualification processes. 3. Assure supplier compliance to GEHC QMS and regulatory requirements through supplier monitoring process. 4. Perform supplier audits as needed for the GEHC LS-Core Imaging manufacturing network. 5. 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. 6. Interface with Suppliers, Engineering, Service, Manufacturing and Sourcing to drive Quality improvements that minimize the Costs of Quality and to ensure GEHC manufactured pharmaceuticals meet product specifications. 7. Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the SCAR process. 7. Demonstrated ability to lead, acknowledge, develop, communicate and implement a strategy to ensure compliance

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 4. Knowledge and understanding of GEHC Purchasing Controls Procedure and associated Work Instructions and operates within them to ensure that all purchased product and services conform to specified requirements 5. Ensure a compliant and qualified supply base by conducting supplier evaluations.


Qualifications: 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. Proficiency with Microsoft Excel spreadsheet development and analysis. 3. Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally). Preferred Qualifications: 1. Ability to effectively communicate within all levels of the organization 2. Demonstrated collaboration, negotiation & conflict resolution skills. 3. Excellent oral communication & report-writing skills.

**Desired Characteristics:**

1. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of site level products and related processes.

2. 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 and risk management; and product quality improvement using tools such as six sigma, DFR, etc.

3. Demonstrated collaboration, negotiation and conflict resolution skills.

4. Experience of working with standards ISO9001, ISO13485, 21CFR/820, ISO11137/11135, ISO12207, IEC-2207, 21CFR 210 & 211.

5. Experience of auditing to ISO, GMP, 21CFR 820, & 21CFR 210 & 211 standards.

5. Excellent oral communication & report, business correspondence & procedure-writing skills.

6. Prior GE experience (GE Healthcare preferred)

**Locations:** United States; Illinois; Arlington Heights

GE will only employ those who are legally authorized to work in the United States for this opening.