Director Global CAPA Programs (Remote, US)

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

Responsible for leading Getinge Global CAPA Continuous Improvement activities supporting Getinge by addressing three core challenges: Competency, Culture and Complexity with the goal to build expertise, foster shared accountability and simplify processes to enable faster, more effective problem resolution and continuous improvement across the Getinge organization. The position supports Getinge's products under the Acute Care Therapy, Surgical Workflow and the Life Science business areas.

Job Responsibilities and Essential Duties

• Lead cross functional teams to upgrade and improve performance of Getinge's end-to-end CAPA System (NC and CAPA).
• Assesses health of system (compliance, efficiency, performance) and manages a portfolio of improvement projects.
• Support Getinge Entities in audit (internal and external) activities.
• Engage with stakeholders, including customers and suppliers, to gather feedback and ensure that their requirements are integrated into the Getinge CAPA system.
• Ensure compliance with the company's Quality System policies and procedures.
• Conduct training sessions and workshops and serve as a CAPA coach to educate resources on the CAPA System.
• Participate in industry & FDA conferences to stay current on enforcement priorities and upcoming changes.
• The position will be responsible for developing and managing personnel
• Internal and External Contacts/Relationships includeQuality & Regulatory Affairs Senior Leaders, Global Process Caretakers, Functional leads in BA (ACT, SW, LS), Global Sales & Service and Operational Services (Logistics), Local Quality Managers (LQMs) and Global Regulators - FDA, Notified Bodies, Competent Authorities, etc.

Required Knowledge, Skills and Abilities

• 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).
• A minimum of 10 years related experience in a medical device quality process areas
• Subject matter knowledge in CAPA and NC processes (CAPA System)
• Strong understanding of Quality Management System operations and application of Global Regulations, ISO standards and management controls.
• High level of influence and mediation skills; can facilitate bringing people from different perspectives to consensus.
• Internal and External Audit Experience; participation in observation response writing and/or working groups.
• Consent decree and remediation activities
• Strategic QMS thinker with excellent analytical and problem solving skills
• Demonstrated ability to work collaboratively in a cross-functional, matrixed environment.
• General understanding of reporting tools (Crystal Reports, Power BI)
• Effective written and verbal communication, including technical writing skills
• Proficiency with Microsoft Office Suite (Word, Excel, Outlook, Teams, Sharepoint, Powerpoint)

Preferred Qualifications:

• Trackwise application experience
• Certification in quality management (e.g., Six Sigma, CQM, ISO Lead Auditor)

The base salary for the position is a minimum of $183,000 and a maximum of $210,000, plus 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.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.