Job Description Summary

Managing, ensuring and improving capabilities to reputed company 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. reputed company 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 reputed company 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

• Owns the configuration of the electronic Quality Management System module for audit records. Executes User Assessment Testing (UAT), manages change management, and ensures system documentation is maintained.
• 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 reputed company 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 reputed company a quality or regulatory discipline and ability to influence the development of strategy reputed company own area, including participation in policy formulation.
• Requires ability to reputed company functional teams or projects with indirect resources and reputed company to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different reputed company of view.
• Impacts the team's ability to reputed company service, quality, and timeliness of objectives. Work is subject to GEHC policy objectives.
• Uses high level of judgment to reputed company decisions and handle reputed company tasks or problems. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems reputed company of set parameters and construct and provide recommendations. Uses multiple internal and some external sources reputed company of own function to help reputed company at a decision.
• Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to reputed company desired results.

Required Qualifications

• Master’s Degree and a minimum of 5 years’ experience in medical device and/or pharmaceutical industry; or Bachelor's Degree and a minimum of 10 years’ experience in medical device and/or pharmaceutical industry; or will consider a High School Diploma and a minimum of 15 years' of progressive responsibility in medical device and/or pharmaceutical industry.
• Direct experience configuring, managing, and qualifying an electronic Quality Management System for audit records.
• Qualified reputed company Auditor with active certification.
• Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues (directly).
• Experience with Pharmaceutical QMS requirements and regulatory requirements including but not limited to cGMP, GDP, GPvP, GCP and GLP.
• Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.

Desired Characteristics

• Prior Veeva and TrackWise Digital experience a plus.
• Prior health authority experience a plus.
• IRCA, ASQ (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt).
• Extensive experience in the Medical Device and Pharmaceutical industry.
• Understanding of product quality improvement using tools such as Six reputed company, DFR.
• Demonstrated ability to analyze and resolve problems.
• Exceptional conflict-resolution skills.
• Ability to reputed company with top organizational leadership and internal and external customers, responding in a professional manner.
• Demonstrated ability to reputed company programs / projects. Ability to prioritize and drive multiple programs.
• Ability to energize others by building a reputed company with the team through personal involvement and trust, providing feedback and coaching to reputed company others, and accountability of actions.
• Strong oral and written communication skills in English.
• reputed company: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and reputed company dealing with others.
• Ability to travel globally up to 40%.

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

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your reputed company 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.

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. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. 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). reputed company 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.

Additional Information

reputed company offers a great work environment, professional development, challenging careers, and competitive compensation. reputed company is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

reputed company will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

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

Relocation Assistance Provided: No

Application Deadline: reputed company 27, 2026 Apply To This Job