Lead Quality Specialist

GE HealthCare•Troy, NY

8d•Onsite

About The Position

Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards. In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the business. GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Requirements

Bachelor’s Degree or a minimum of 4 years of relevant experience in Quality Management or a related field
Hands-on experience managing a Quality Management System (QMS), including internal audits, document control, and procedural updates
Experience working in a regulated manufacturing environment (ISO standards), ideally within medical devices or related industries
Experience working in a clean room and/or semiconductor environment
Experience supporting or working with complex product lines (e.g., digital X-ray detectors or similar technologies)
Demonstrated ability to work effectively in a smaller, fast-paced team environment where individuals take on multiple responsibilities
Strong collaboration skills with the ability to partner cross-functionally and drive alignment across teams
Effective written and verbal communication skills, including the ability to explain complex concepts clearly
Proficiency with Microsoft Office tools (Word, Excel, PowerPoint, etc.)
Ability to manage multiple priorities and operate with strong self-direction and accountability

Nice To Haves

3+ years of experience in a regulated industry
Familiarity with ISO 13485 and medical device Quality Management System requirements
Experience with key quality processes such as CAPA, internal/external audits, and root cause analysis
Exposure to product lifecycle activities, including design changes, validation, and process control methodologies
Experience interfacing with regulatory bodies or supporting inspections
Strong analytical and problem-solving skills with the ability to identify and resolve complex issues
Demonstrated ability to contribute to or lead process improvements or change initiatives

Responsibilities

Responsible for the Quality Management System and Compliance activities for the site
Creates a Quality culture by driving compliance activities and Quality metrics
Ensures quality and regulatory compliance while driving process effectiveness and efficiency
Utilize proven interpersonal skills to communicate with direct colleagues and the business.
Provides informal guidance to team members.
Concisely explains complex information to others.
Operates with some autonomy, activities require professional judgment
Utilizes professional experience, technical skills, and analytical thinking to provide compliance guidance to colleagues and assist with problem resolution.
May use multiple internal sources outside of own team to arrive at decisions.
Applies technical writing skill to maintain Quality procedures
Represents GE HealthCare to external agencies