Quality Lead Specialist 2 - Healthcare Quality
Indianapolis (Hamilton) Design / Civil engineering / Industrial engineering
Job description
3156079
Additional Cities
Bengaluru
Career Level
Experienced
Relocation Assistance
Yes
Business
GE Healthcare
Business Segment
Healthcare Quality
Function
Quality
Country/Territory
India
Postal Code
560 066
Role Summary/Purpose
This position is responsible for providing 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 design & Development activities and related quality Compliance.
Essential Responsibilities
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 to ensure compliance. 3. Responsible for the development, implementation, and continuous improvement of process effectiveness and efficiency at the site. 4. Has working knowledge of ISO 13485, ISO 14971, FDA QSR 820.30 & SDLC process. 5. Leads process efficiency and compliance effectiveness through the development and implementation of process verification and validation plans, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks and impacts. 6. Supports continuous product and process improvement through detailed failure analysis for non-conformances, 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). 7. Utilizes risk management tools and aids for use by the organization in accordance with documented procedures, including but not limited to PFMEA, DFMEA, Fault Tree Analysis, Failure Mode Analysis, etc. Supports design mitigation efforts. Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process. 8. Ensures process compliance through the development of comprehensive procedures, work instructions, flowcharts, forms, templates, checklists, worksheets, and other product and process related documentation. 9. If managing a team, provides guidance and facilitates problem resolution, resource utilization, career counseling, coaching and mentoring of team members as applicable. 10. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.
Qualifications/Requirements
1. Bachelor's Degree or a minimum of 6 years work experience. 2. Minimum of 3 year experience working in a regulated industry or a Masters degree 3. Ability to communicate effectively in English (both written and oral). 4. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Desired Characteristics
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.
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.
Primary Country
India
Primary State/Province
Karnataka
Primary City
Bengaluru