Director, Central Quality Audit

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $142.4k - $213.6k / year

⏰ Full Time

🔴 Lead

👔 Director

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GE HealthCare

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1892

💊 Pharmaceuticals

Healthcare • Medical Technology • Pharmaceuticals

GE HealthCare is a leader in precision care, dedicated to providing innovative technologies and integrated solutions that enhance healthcare services. As a stand-alone company, it focuses on imaging, ultrasound, and healthcare IT, empowering clinicians and improving patient outcomes through advanced medical technologies and personalized care solutions. With a significant investment in research and development, GE HealthCare aims to transform healthcare by making hospitals more efficient and therapies more precise.

📋 Description

• Managing, ensuring and improving capabilities to comply with external standards and regulations • Interprets internal and external business challenges and recommends best practices to improve products, processes or services • Executes against GEHC's Central Quality & Regulatory Audit program • Scheduling, preparation, execution, reporting, and follow-up activities associated with Central Quality & Regulatory Internal Audits • Identification and communication of high-risk issues • Reporting compliance concerns and recommended improvements to business leadership • Ensures audit strategy is executed to current industry practices and regulatory expectations • Supports GEHC Health / Competent Authority audits • Preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities • Supports GEHC Quality Management System by defining, tracking, and maintaining metrics to promote early awareness and visibility of Quality & Regulatory issues • Regularly advises management in Central Quality • Communicates difficult concepts and influences others' options on topics

🎯 Requirements

• Qualified Lead Auditor with active certification • Master’s Degree and a minimum of 5 years’ experience in the medical device industry; or Bachelor's Degree and a minimum of 10 years’ experience in the medical device industry; or will consider a High School Diploma and a minimum of 15 years' of progressive responsibility in the medical device industry • Minimum of 5 years’ Experience driving Global programs to resolve quality compliance issues (directly) • Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485 • Prior notified body or health authority experience a plus • ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt) • Design controls, design verification and validation activities • Production and process controls • Class III US FDA PMA Device requirements • CAPA, complaints and risk management • Understanding of product quality improvement using tools such as Six Sigma, DFR • Demonstrated ability to analyze and resolve problems • Exceptional conflict-resolution skills • Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner • Strong oral and written communication skills in English • Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.

🏖️ Benefits

• medical • dental • vision • paid time off • a 401(k) plan with employee and company contribution opportunities • life • disability • accident insurance • tuition reimbursement