Sr. Director Field Actions and CAPAs - Remote

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

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. Director Quality Field Actions & CAPA. This position leads and oversees the deployment and management of the Field action and CAPA processes across Getinge to achieve strategic quality objectives, certification, and continuous improvement.

As a Global Caretaker, you are responsible to develop, improve and manage global processes through empowered communities of practice engaging with users and stakeholders.

 

Job Responsibilities

Quality Management System (GETQMS) process caretaker for Global Field Action and CAPA processes overseas:

• End to End process leadership for Global Field action and CAPA process
• Provide direction and support for the Global Caretaker for CAPA
• Engage SME’s in continuous improvement through a “Community of Practice” model 
• Create annual Goals and Objectives
• Ensuring timely resolution of CAPAs associated with the process
• Supporting external audits of process activities
• Upgrade and improve performance of company’s end-to-end Field Action and CAPA  processes. Assesses health of system (compliance, efficiency, performance) and manages a portfolio of improvement projects.
• Upgrade and improve the quality of external stakeholder communications, specifically regulators and customers.
• Participates in industry & FDA conferences to stay current on enforcement priorities and upcoming changes. 
• Engage with stakeholders, including customers and suppliers, to gather feedback and ensure that their requirements are integrated into the Getinge Field Action and CAPA system.
• Establish and manage robust management controls framework for all Field Action and CAPA processes to track Key Performance Indicators (KPIs) and to monitor quality trends for the corporation and across the sites / BA’s.
• Utilize the management review process as a strategic tool to foster cross-functional collaboration and synchronize quality improvement initiatives across Getinge.
• Conduct training sessions and workshops to educate employees about the significance of compliance with all Field Action and CAPA processes.

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 in a medical device manufacturing environment and managing global teams
• Strong understanding of Quality Management System operations and application of the Regulations, ISO standards, and management controls.
• Can present Getinge QMS during the inspection / audit and at working groups.

• Consent decree and remediation activities experience required.
• Certification in quality management (e.g., Six Sigma, CQM, ISO Lead Auditor) is preferred.
• IT skills related to operating various Microsoft and other systems

#LI-DV1

 

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

 

If you share our passion and believe that saving live