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; and 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.
• Requires 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.
• Requires ability to lead functional teams or projects with indirect resources and medium to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view.
• Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GEHC policy objectives.
• Uses high level of judgment to make decisions and handle complex tasks or problems. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
• Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results.

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.
• 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.
• 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%.

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.

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