Supplier Quality Leader

at  GE Healthcare

JOB DESCRIPTION SUMMARY

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
This position is responsible for maintaining quality oversight for Contract Manufacturing Operations (CMO’s) utilized by GE Healthcare Pharmaceutical Diagnostic (PDx) Division.
Develop, monitor and maintain positive relationships with GE our External CMO partners encouraging strong collaboration, continuous improvement, transparency and accountability. To ensure manufactured sterile Finished Product meet or exceed GE Healthcare quality, safety and regulatory requirements.

REQUIRED QUALIFICATIONS

• Bachelors Degree in Science discipline (or non-technical degree with significant experience in manufacturing, engineering or equivalent knowledge or experience or quality assurance experience, or an Associate’s Degree with major manufacturing, engineering, or quality assurance experience) or equivalent knowledge or experience.
• Several years of professional experience in supplier quality/ quality operations
• Effective problem solving, root-cause analytical skills to lead and influence others to drive change (cross-functionally and globally).
• Proficiency with Microsoft Excel spreadsheet development and analysis.
• An ability to travel (up to 30%)

• Complete supplier qualification activities for prospective Contract Manufacturing Operations.
• Maintain quality oversight for a number of Contract Manufacturing Operations.
• Act as a single point of contact for all quality related activities at Contract Manufacturer.
• Manage all critical quality related issues (deviations, complaints, regulatory non-compliances etc)
• Assure Corrective and Preventive Action plans are developed and executed appropriately.
• Develop and maintain Quality Agreements between GE Healthcare and Contract Manufacturers.
• Responsible for the coordination and completion of audits, participating in and/or leading audits.
• Ensure Change Controls, initiated by supplier or by GE Healthcare are managed appropriately.
• Assist in Health Authority inspection preparations and providing support throughout as required.
• Track and trend key quality indicators / metrics to monitor supplier and QMS performance.
• Assure suppliers comply with all GE Healthcare QMS, procedures and regulatory requirements.
• Develop positive relationships with all internal partners, i.e. Sites, Sourcing, Supply Chain etc
• Provide quality support for New Product Introductions and transfers project activities.
• Interact with Suppliers, Sites and Sourcing to drive improvements to minimize costs of quality.
• All other duties as assigned by manager