Senior Associate Specialist,Quality

Overview

Senior Associate Specialist in Quality at GE HealthCare, responsible for driving Quality and regulatory compliance activities for a specific product, site or region within the Quality management system.

What you'll do

• Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements.
• Ensure projects and products are capable and will meet specified standards (preventive).
• Create a Quality culture by driving compliance activities around a specific product, site or region.
• Be responsible for the total quality management system for the business and drive Quality metrics.
• Ensure quality and regulatory compliance while driving process effectiveness and efficiency.
• Resolve issues in situations that require good knowledge and judgment within established procedures.
• Consult more senior team members for issues outside of defined policy/parameters.
• Explain technical information to others.

What you'll need

• Bachelor's degree from an accredited university or college.
• Minimum 5+ years of relevant experience.
• Awareness of Software Development Methodologies and Computer system validations.
• Knowledge of ISO 13485 standards, ISO 14971 standards, IEC 62304 and medical device regulations.

Nice to have

• Strong oral and written communication skills.
• Ability to document, plan, market, and execute programs.
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA 21 CFR 820, IEC 62304-2006 (Medical Device Software), and ISO 13485.
• Good interpersonal skills.

Details

• Location: Bengaluru, India (EPIP 122 (Phase II)).
• Relocation assistance: not provided.