VP, Quality Operations ACT

 

 

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 Vice President, Quality Operations ACT within our global Acute Care Therapy (ACT) business area. The ACT business area is the largest of 3 Getinge business areas with responsibility for designing and manufacturing lifesaving medical products for use in cardiovascular surgery, critical care, and intensive care.  The ACT business area is geographically distributed with manufacturing sites in the U.S., Germany, France, Sweden, Turkey, and China.  This key leadership role will ensure continued quality operations and progressing on the compliance journey.  The Vice President is responsible for leading the development and improvement of the Quality Operations capabilities, and enhancing and supporting the continuous improvement of product and quality system performance, globally. 

 

This position may be based at any Getinge location.  Remote locations may be considered for the right candidate if based in a time zone that can virtually support the business locations.

 

Job Responsibilities:

Site locations- US, France, Germany, Sweden, Turkey

• Lead quality operations for the Acute Care Therapy division, ensuring compliance with worldwide regulatory standards and internal policies.
• Oversee the execution of internal and external audits, ensuring compliance with ISO standards, FDA regulations, and other relevant requirements.
• Establish and lead a robust CAPA governance board that addresses compliance gaps and meet the requirements of the consent decree.
• Collaborate with cross-functional teams, including R&D, manufacturing, supply chain, and regulatory affairs, to ensure quality is integrated throughout the product lifecycle and compliance gaps are closed.
• Lead and mentor a team of quality professionals, fostering a culture of quality excellence and professional development.
• Ensure timely and effective resolution of quality issues, including non-conformances, customer complaints, and audit findings, with a focus on addressing consent decree requirements.
• Develop and monitor key performance indicators (KPIs) to measure the effectiveness of quality operations and drive improvements, specifically targeting compliance issues.
• Lead the cross-functional Risk Management Board. Enable robust decision making for Field actions, Health Hazards, risk management activities, including Failure Mode and Effects Analysis (FMEA) and root cause analysis.
• Lead budget and organizational structure development and management including planning for future needs and skill sets.
• Stay abreast of industry trends, regulatory changes, and best practices to continuously enhance the quality operations function and ensure ongoing compliance.
• Benchmarks internal and external organizations, identifies, implements, leverages, and transfers best practices knowledge to ACT.
• Partner with Corporate Quality on GetQMS, procedures, and tools
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