What are the responsibilities and job description for the Director ACT Quality- Internal Auditing position at Maquet Cardiovascular LLC?
With a passion for life
Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.
Are you looking for an inspiring career? You just found it.
Job Overview
This Quality Director role leads and oversees the development, implementation, and continuous improvement of multiple Quality Management Systems in compliance with medical device regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820) within the Acute Care Therapies (ACT Business Unit.
The Director responsible for Business Unit Auditing is a key leadership role responsible for overseeing the audit readiness processes of ACT, including direct responsibility for Regulatory Authority and Notified Body audit support, alignment with corporate auditing team, and the coordination of the internal audit process.
The position demonstrates strategic thinking with deep knowledge of the medical device industry and regulatory compliance. The Director will partner with executive leadership and various departments to safeguard the company’s integrity, support operational excellence, and enhance stakeholder confidence.
Job Responsibilities and Essential Duties
- Strategic Leadership : In partnership with the Senior Director of Corporate Auditing, QRC develop and implement a Global Internal QMS framework and drive strategic initiatives. Lead the design, implementation, and maintenance of the internal QMS framework to ensure compliance with global medical device regulations and standards with a special focus on both external and internal audit signals. Assesses health of system (compliance, efficiency, performance) by developing and monitoring key quality metrics and manages a portfolio of improvement actions / projects.
- Internal auditing : Work with the external, corporate and site internal audit teams to upgrade and improve internal auditing processes resulting in greater actional insights across the company.
- Management Controls : Working with the management controls owners, continue to upgrade and improve the performance of the company’s management controls processes. Assesses health of system (compliance, efficiency, performance) by developing and monitoring key quality metrics and manages a portfolio of improvement actions / projects.
- Inspection Readiness : Identify and implement best practices to ensure entities are prepared to successfully support regulatory authority and notified body audits.
- Resource Management : Provide inputs to efficiently allocate and manage resources to optimize project outcomes. Provide leadership and mentorship to project management and Quality & Regulatory teams.
- Continuous Improvement : Drive a culture of continuous improvement by identifying areas for enhancement in quality processes. Implement best practices to enhance overall efficiency and effectiveness.
- Communication and Reporting : Upgrade and improve the quality of stakeholder communications. Effectively communicate strategy, updates, milestones, and challenges across Getinge to all stakeholders.
- Industry Engagement : Participates in industry & FDA conferences to stay informed on the latest trends, regulations, and best practices in auditing and compliance. Collaborate with senior leadership to assess and address emerging risks, industry trends, and regulatory changes.
- Responsible for the indirect development and management of personnel and programs in alignment with the project and activities needs.
- Build Quality into all aspects of Getinge work by maintaining compliance to the applicable quality requirements depicted in the GetQMS directives.
- Responsible for the leadership of Getinge ACT’s quality auditing processes.
Minimum Requirements
The base salary for the position is a minimum of 195,000 and a maximum of $244,000, plus an annual bonus of 30%
About us
With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.
Benefits at Getinge :
At Getinge, we offer a comprehensive benefits package, which includes :
Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law. Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.
Salary : $244,000
