Senior Lead Specialist, Quality, QMS, Training and Audits Leader

Job Description SummaryManage essential quality system management control processes for a large GE HealthCare design and manufacturing center. Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements (e.g. 21 CFR 820, ISO 13485, EU MDR, etc.).
Own site internal audit program, QMS, and training programs. Drive site quality objectives. Manage and maintain external audit readiness as well as represent GE HealthCare to external agencies.
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 area.
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.

Job Description

Roles and Responsibilities

• Creates a Quality culture by driving compliance activities for a large GE HealthCare design and manufacturing site within the areas of audits, QMS document management and training.
• Ensures quality and regulatory compliance (e.g. 21 CFR 820, ISO 13485, MDSAP) while driving process effectiveness and efficiency. Ensures records are generated, reviewed and approved according to applicable procedures
• Maintain product and site certifications through external audits, including representing GE HealthCare to external agencies during audits.
• Drive external audit readiness, ensuring cross-functional engagement and timely action closure
• Lead site internal audit program through management of the audit plan, execution, and results, and by conducting audits
• Manage (develop, maintain and improve) the site quality management system and associated processes for compliance and efficiency
• Manage QMS training planning, assignment, and drive training completion to plan
• Apply Lean methodologies to improve daily work and simplify processes
• Support site quality assurance tasks and activities, as needed

Required Qualifications

• Bachelor's degree from an accredited university or college (or at least 6 years of relevant work experience in Medical Devices, or similar regulated industry)
• 2+ years of professional experience.
• Legal authorization to work in the U.S. is required. Sponsorship for employment visas, now or in the future, for this job opening is not available.

Desired Characteristics

• Demonstrated understanding of Medical Device Quality Management System requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Established project management skills. Ability to lead cross-functional teams to plan and execute projects on time.
• Aptitude with digital workflows and IT systems.
• Ability to effectively manage execution of tasks with competing priorities.
• Strong oral and written communication skills.
• Demonstrated ability to analyze and resolve problems.
• Demonstrated collaboration and conflict resolution skills.
• Strong interpersonal and leadership skills.

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

Additional Information

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.