Director, Central Quality Audit

Roles and Responsibilities

• Executes against GEHC's Central Quality & Regulatory Audit program.
• This includes 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;
• ensuring audit strategy is executed to current industry practices and regulatory expectations.
• Supports GEHC Health / Competent Authority audits.
• This includes 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.

Required Qualifications

• 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.

Desired Characteristics

• Prior notified body or health authority experience a plus.
• AQSC 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.
• Demonstrated ability to lead programs / projects.
• Ability to prioritize and drive multiple programs.
• Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions.
• 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.
• Ability to travel domestically and internationally up to 40%.

Benefits

• We will not sponsor individuals for employment visas, now or in the future, for this job opening.
• For U.S. based positions only, the pay range for this position is $142,400.00-$213,600.00 Annual.
• The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location.
• In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI).
• GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

About the Role

• Manages, ensures and improves capabilities to comply with external standards and regulations.
• Interprets internal and external business challenges and recommends best practices to improve products, processes or services.
• Stays informed of industry trends that may influence work.

Skills

• Specialized depth and/or breadth of expertise within a quality or regulatory discipline and ability to influence the development of strategy within own area, including participation in policy formulation.
• Leading functional teams or projects with indirect resources and medium to high risk and/or complexity.
• Communicating difficult concepts and influencing others' options on topics.
• Offering new solutions to problems outside of set parameters and constructing and providing recommendations.
• Using multiple internal and some external sources outside of own function to help arrive at a decision.
• Developing self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results.

Qualifications

• 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.