Director Global CAPA Programs (Remote, US)

Getinge•Dallas, TX

1d•$183,000 - $210,000•Remote

About The Position

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.

Requirements

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)

Nice To Haves

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

Responsibilities

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.