General Electric Supplier Capability and Process Engineer in Westborough, Massachusetts

Role Summary:

This role is responsible driving exceptional product quality for our customers and optimized Cost of Quality for GEHC. This is a key technical position, affecting product quality for both installed base and new product introductions, by driving supplier capability assessment and development along with a robust hand-off between GEHC engineering and our suppliers. The position reports into a global team and will be supporting the Westborough and other GEHC Life Sciences sites, as required.

Essential Responsibilities:

• Effectively assess and evaluate supplier capabilities used in the supplier selection process.

• Supplier part and process qualification activities (pFMEA, Control plan, GR&R, capability studies, etc.) and Quality Plan Implementation.

• Improve supplier quality performance for assigned suppliers/parts via Key Supplier Collaboration and/or Supplier Development Programs.

• 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 the Costs of Quality, specifically Failed on Arrival/Install (FOA/FOI) issues, Field Failures, and Factory defects. Fulfillment issues due to Supplier Capability/ Quality

• Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.

• Responsible for leading root cause investigations and corrective actions to resolve supplier quality related issues

• Establish and maintain positive relationships with external and internal interfaces to ensure that customer requirements are understood and achieved – suppliers, engineering, service, manufacturing, sourcing, supplier quality.

• Performing supplier audits per audit plan.

• All other duties as assigned by manager.

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

Qualifications/Requirements:

  • Bachelor’s Degree in Engineering - Mechanical, Chemical, Biological, Production, Industrial or equivalent

  • Minimum 12 years of experience from Life Sciences, Pharma or Medical device industry including following:a) Minimum 10 years of experience in manufacturing, design, quality assurance or regulatory assuranceb) Experience in problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally) c) Experience with Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies and in-depth understanding of related processes.

  • Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy to ensure compliance.

  • Proven process development and project management skills.

  • Effective report writing and presentation skills. Desired Characteristics:

  • 4 or more years of experience, with proven leadership, in design or manufacturing.

  • 4 or more years of experience, with proven leadership, in lean manufacturing processes.

  • 4 or more years of experience, with proven leadership, in a quality role, with understanding of QMS implementation.

  • Ability to effectively communicate with all levels of the organization

  • Familiarity with various engineering areas of technology, such as, but not limited to: Single-use technology, Plastics, OEM or CMO (Process & Design capability), Chemistry, Biologics

  • Demonstrated collaboration, negotiation and conflict resolution skills. About Us: 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. www.ge.com GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer at http://www.ge.com/sites/default/files/15-000845%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. Locations: United States; Massachusetts; Westborough, Boston, MarlboroughGE will only employ those who are legally authorized to work in the United States for this opening.