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Role Summary: Responsible for coordination and execution of validation studies in accordance with current Good Manufacturing Practices.
Essential Responsibilities: Lead analysis of defect data and CAPA creation / resolution and maintain records as specified by the GEHC quality system Interface with Supplier Quality on supplier related defects Write and conduct validations (IQ/OQ/PQ) for manufacturing processes and equipment Maintain regular contact with customers to ensure products meet expectations Conduct root cause analysis on product quality issues, identify trends, and communicate with other functional departments for resolution. Reduction of MRB and non-conforming material inventory Develop, establish, and optimize quality inspection methods, test methods, and product specifications Ensure compliance through validation and verification (V&V)
Quality Specific Goals: • Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position • Complete all planned Quality & Compliance training within the defined deadlines • Identify and report any quality or compliance concerns and take immediate corrective action as required • Knowledge and understanding of production process work instructions and operates within them to ensure that a device conforms to its specifications • Ensures the creation of accurate, complete and timely records and DHRs
Qualifications/Requirements: • Bachelors Degree in engineering or science related field or at least 10 years of Quality Engineering experience • 3 years of quality assurance or quality engineering experience • Strong working knowledge of FDA Quality Systems Regulations (21CFR820) (21CFR210) and International Quality System Standards (ISO13485) • Strong communication skills, verbal and written • Working knowledge of Excel, Word, Power Point, Minitab, Statistica • Ability to read and understand CAD drawings • Some traveling may be required (less than 10% of time)
Desired Characteristics: • Green Belt Certified • CQE Certification • Lean manufacturing experience • Strong working knowledge of Current Good Manufacturing Practices (cGMP) • Demonstrated ability to lead • Process management skills • Prior GE Healthcare experience
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