This position is responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Assurance fundamental practices that are utilized in the local business. The role involves hands-on work in the areas of Manufacturing, design transfer, distribution, and/or service.
1. Assists in ensuring 100 percent quality and regulatory compliance in accordance with documented procedures for all aspects of functional responsibility.
2. Leads, acknowledges, develops, communicates & implements a strategy at site to ensure compliance.
3. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site..
4 Supports continuous product and process improvement through detailed failure analysis for non-conformance, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).
5. Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation.
6. If managing a team, provides guidance and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members as applicable.
7. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
1. Bachelor's Degree or a minimum of 4 years work experience.
2. Minimum of 1 year experience working in a regulated industry
3. Ability to communicate effectively in English (both written and oral).
1. Minimum of 3 years experience in a regulated industry is preferred 2. Demonstrated understanding or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485. 3. Demonstrated knowledge of Quality Management System tools, continuous improvement methodologies & in-depth understanding of site level products & related processes 4. Demonstrated expertise to effectively communicate within all levels of the organization around concepts of design controls, design verification and validation activities; production &process controls; Corrective & Preventive Action (CAPA), complaints & risk management; & product quality improvement using tools such as six sigma, DFR, etc. 5. Demonstrated collaboration, negotiation & conflict resolution skills 6. Excellent communication skills (written and oral) 7. Demonstrated ability to lead, acknowledge, develop, communicate & implement a strategy under crisis situations to ensure compliance 8. Demonstrated understanding of product development lifecycles, design change and document change control, process verification and validation methodologies, manufacturing / production process control methodologies, and servicing in a medical device environment. 9. Demonstrated understanding of continuous quality / process improvement tools: (As defined by the local site, e.g. DMIAC, SPC, Lean SS, 5S) 10. Experience leading and implementing change 11. Experience performing internal audits and participating in external audits 12. Exceptional analytical, problem solving & root-cause analysis skills 13. Ability to multi-task & handle tasks with competing priorities effectively 14. Strong technical aptitude (i.e. able to read & comprehend technical documentation & execute procedures), global regulatory experience & demonstrated experience interfacing with regulators.
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.