GE HealthCare is looking to improve its quality management system, product specifications, and applicable standards to ensure manufacturing and/or engineering process support. The role aims to enhance quality culture, ensure regulatory compliance, and drive process effectiveness and efficiency.
Requirements
- Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
- Experience in Quality Assurance, Quality Engineering, Design Engineering or Manufacturing Engineering in a regulated industry.
- Demonstrated expertise to effectively communicate within different functions and different levels of the organization around QMS concepts including Production & Process Controls, Corrective & Preventive Action (CAPA), Risk Management and Product Quality.
- Demonstrated understanding of design change, document change control and manufacturing/production process change control processes and methodologies.
- Ability to demonstrate analytical, problem solving & root-cause analysis skills along with experience leading and implementing change.
- Strong technical aptitude (i.e., able to read & comprehend technical documentation & provide technical feedback)
- Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.
Responsibilities
- Leads process efficiency and compliance effectiveness through the development and implementation of equipment qualification and process validation, 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.
- Utilizes risk management tools including but not limited to pFMEA/dFMEA.
- 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).
- Creates a Quality culture by driving compliance activities around a specific product, site or region.
- Ensures quality and regulatory compliance while driving process effectiveness and efficiency through the implementation of lean processes and standard work.
- Uses judgment to make decisions or solve moderately complex tasks or problems.
- Takes new perspective on existing solutions.
Other
- Bachelor's degree from an accredited university/college or a minimum of 6 years of relevant work experience in Medical Devices, or similar regulated industry.
- Minimum of 3 years of experience working in a regulated industry.
- Ability to communicate effectively in English (both written and oral).
- Skilled influencer, able to communicate complex messages to others.
- Demonstrated collaboration, negotiation, and conflict resolution skills.
