Sr Quality Director, Global Quality & Regulatory Compliance

 

 

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.

 

 

 

Getinge is a global company that designs and manufactures medical devices and life science equipment. We impact the environment in various ways during a products life cycle so we have a goal to be CO2 neutral by 2025 and we are also engaged in achieving the Paris Agreement goal of limiting global warming to 1.5°C above pre-industrial levels.

 

We are focused on the pride and passion we have in belonging to Getinge and how our employees can share a passion to be part of a company with the central purpose of saving lives. We are looking for individuals who share this passion to join our team.

 

We currently have an opening for a Sr. Quality Director, Global Quality & Regulatory Compliance. This position leads and oversees the development, implementation, and continuous improvement of GetQMS, Getinge’s global Quality Management System in compliance with medical device regulations and standards (e.g., ISO 13485, FDA 21 CFR Part 820). This is a strategic role leading a group of QMS process Caretakers with direct responsibility for management controls, internal auditing, document control & quality training. Process caretakers develop, improve and manage global processes through empowered communities of practice engaging with users and stakeholders.

 

Key Responsibilities

• Strategic Leadership: In partnership with the SVP of Global QRC develop and implement GetQMS, Getinge’s Global QMS framework, and drive strategic initiatives. Lead the design, implementation, and maintenance of GetQMS to ensure compliance with global medical device regulations and standards while delivering operational excellence including the supporting IT roadmap.
• Management Controls: Working with the management controls caretaker 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.
• Internal & External auditing: Work with the corporate and site internal audit teams to upgrade and improve internal auditing processes resulting in greater actional insights across the company. Supporting external audits of process activities.
• Document control & training: Oversee document control processes, ensuring that all quality-related documentation is accurate, up-to-date, and compliant with regulatory requirements. Working in partnership with Getinge’s training academy ensure that all employees are adequately trained on the GetQMS and relevant regulatory requirements, providing ongoing training and support as needed.
• Resource Management: 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 GetQMS 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 quality systems and compliance.

 

Knowledge/Skills/Experience:

• Master’s Degree in a relevant field (e.g., Business Administration, Quality Management, or other; related science discipline or equivalent combination of education and experience is required). 12+ years related experience i