Quality Oversight Specialist
3 settimane fa
**Quality Assurance Role at GE Healthcare**
GE Healthcare is a leading medical technology and digital solutions innovator. We're committed to improving lives in the moments that matter. As a key member of our team, you'll have the opportunity to make a real difference in the healthcare industry.
**Job Summary**
This position is responsible for maintaining quality oversight for Contract Manufacturing Operations (CMO's) utilized by GE Healthcare Pharmaceutical Diagnostic (PDx) Division. You'll develop, monitor, and maintain positive relationships with our external CMO partners, encouraging strong collaboration, continuous improvement, transparency, and accountability.
**Key Responsibilities**
- 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 Manufacturers
- 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 provide 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.
**Requirements**
- Bachelor's Degree in a Science discipline (or non-technical degree with significant experience in manufacturing, engineering, 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
- Ability to travel (up to 30%)
**Additional Information**
We offer a competitive salary and benefits package, as well as opportunities for career growth and development. If you're a motivated and detail-oriented individual with a passion for quality assurance, we encourage you to apply for this exciting opportunity.
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