GE HealthCare is hiring a Director, Central Quality Audit to execute our Central Quality & Regulatory Audit program globally. In this role, you will be responsible for the full audit lifecycle, support Health Authority inspections, and maintain our Quality Management System through metrics and leadership.
What You'll Do
- Execute the Central Quality & Regulatory Audit program, including scheduling, preparation, execution, reporting, and follow-up.
- Support Health Authority/Competent Authority audits, including preparation, back-room management, and tracking Lessons Learned.
- Support the Quality Management System by defining, tracking, and maintaining metrics to promote early awareness of Quality & Regulatory issues.
- Advise management in Central Quality on a regular basis.
- Lead functional teams or projects with indirect resources and medium to high risk/complexity.
- Develop self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship.
What We're Looking For
- Qualified Lead Auditor with active certification.
- Master’s Degree and a minimum of 7 years’ experience in the medical device industry; OR Bachelor's Degree and a minimum of 9 years’ experience 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 FDA CFR 21 820 and ISO 13485.
- Experience with auditing to ISO 17025, reviewing sterilization validations, protocols, SOPs, reports, and knowledge of ISO 10993 series, ISO 17664, ISO 11135, ISO 11137, data integrity, sample handling, and laboratory equipment including IQ, OQ, PQ, GLP, and GMP, as well as terminal sterilization methods.
Nice to Have
- Prior notified body or health authority experience.
- ASQ Certification (CQE, CQA, etc.) and/or Lean Certification (green belt, black belt).
- Software Quality Engineer (CSQE) certification strongly preferred.
- Experience with design controls, design verification, and validation activities.
- Experience with production and process controls.
- Experience with Class III US FDA PMA Device requirements.
- Experience with 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/external customers.
- Demonstrated ability to lead programs/projects and prioritize multiple programs.
- Ability to energize others through personal involvement, trust, feedback, coaching, and accountability.
- Strong oral and written communication skills in English.
- High integrity and adherence to ethical values.
- Ability to travel domestically and internationally up to 40%.
Team & Environment
You will lead functional teams or projects with indirect resources, advising management and driving global quality initiatives.
Benefits & Compensation
- Compensation range: $139,200.00-$208,800.00 Annual
- Medical, dental, vision insurance
- Paid time off
- 401(k) plan with employee and company contribution opportunities
- Life, disability, and accident insurance
- Tuition reimbursement
- Performance based incentive compensation (cash bonus(es) and/or long term incentives)
GE HealthCare provides equal opportunity to all without discrimination based on race, color, religion, national or ethnic origin, gender, sexual orientation, gender identity or expression, age, disability, protected veteran status, or other legally protected characteristics.
