Location(s): United States ; California; Sunnyvale
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. 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: In this role, CAPA Engineering Leader is responsible for creating and supporting a Quality culture across sites by driving compliance activities around the CAPA Program, managing continuous process/quality improvements and demonstrate compliance during internal and external audit/inspection opportunities.
Essential Responsibilities: • Hands-on engineering role to perform root cause/impact analysis of Corrective & Preventive actions with the engineering teams, and effectively document in GE Healthcare’s CAPA Management system. • End-to-end ownership across the entire CAPA cycle from non-compliance to investigations to Corrective/Preventative Actions including writing the associated documents • Drive compliant behavior within the Quality Management System for ABUS products including audit support, evaluation of non-conformities, support of investigations, and execution of Corrective Actions / Preventive Actions (CAPA). Conduct periodic evaluation of the Risk Mitigation Table. Monitor process timeliness and compliance within the Spirit and Letter of the QMS in order to remain compliant, reduce cost, and improve the ABUS customer experience • Leading CAPA activities including coordination/management of overall CA/PA system, CAPA Impact Analyses, and Product Field Action Coordination and execution • Ensuring regulatory compliance and optimization of quality system procedures relating to CAPA, complaint handling, adverse event reporting and product field actions through development, maintenance and improvement of documented processes, development and implementation of employee training, and development and implementation of quality metrics to drive improvement and business results • Identify and report any quality or compliance concerns and take immediate corrective action as required
Qualifications/Requirements: 1. Bachelor's degree or higher 2. Minimum 5 years experience as an engineer in a medical device or pharmaceutical industry. 3. Minimum 5 years experience applying regulations (including FDA QSR, ISO13485). 4. Experience with CAPA process and implementation. 5. Supervisory experience 6. Ability to work independently in fast-paced environment with little supervision. 7. Ability to identify root cause of problem, and creatively problem-solve to gain resolution. 8. Ability to communicate effectively (both written and oral). 9. Ability to adapt to constant change. 10. Team-oriented and responsive to customer needs.
Desired Characteristics: 1. Experience with CAPA program in a medical device industry. 2. Strong problem solving skills. 3. Quality-focused, attentive to detail and results-oriented. 4. Ability to influence positive change effectively. 5. Team-oriented and responsive to customer needs. 6. Stress Tolerance: Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging circumstances. 7. Dependability: Being reliable, responsible, dedicated, committed and fulfilling obligations 8. Adaptable/Flexible: Being open to change (positive or negative) in response to new information, different or unexpected circumstances, and/or to work in ambiguous situations 9. Ability to identify root cause of problem, and creatively problem solve to gain resolution.
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