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Director, Quality Excellence Complaint Handling
2 months ago
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 Director, Quality Excellence Complaint Handling. This position is responsible for leading a continuous improvement team in the complaint handling and vigilance space, including utilization of technology to improve quality and efficiency, continuously striving for “Best in Class”. Provide actionable data to the organization, working with Designated Complaint Handling Units, Business Area and Sales and Service to drive continuous improvement, efficiencies. Leads Monthly Complaint Business Review (Health of the Complaint System)/Tiered Management/Complaint Data.
Essential Duties
Leads Designated Complaint Handling Continuous improvement team, achieves year over year quality and efficiency improvements in the complaint handling/vigilance space Leads Monthly Business Review, including the assignment and follow through of actions to improve overall health of the complaint handling and vigilance system. Partners with SSU, BA, PA, Medical Affairs and other functions to achieve Key Performance Indicators Drives efficiency and compliance in complaint file processing through the use of data and technology. Ensure consistency and excellence in Complaint Handling and vigilance processes and work developing new or improved techniques and procedures based on community of practice input, best practice and new and changing regulation. Ensure compliance with applicable regulation including but not limited to: Food and Drug Administration (FDA), EU MDR, Organization of International Standards (ISO), Quality System Regulation, and other applicable regulatory requirements, as they relate to the complaint handling processes. Ensure compliance with the company’s Quality System policies and procedures. Regulatory presentations, summary reports, and meeting attendance, including changes to complaints database functionality as needed to maintain compliance. Provide input in requests from US and/or OUS regulators, as required. Provide regular updates/reports to senior management.Required Knowledge, Skills and Abilities
Bachelor’s Degree in Science discipline or equivalent combination of education is required, plus 7 years’ experience in medical device. Subject matter knowledge in medical device complaint handling, vigilance and post market processes and regulation. High level of communication skills for all kinds of audiences; translate quality and regulatory words and concepts into easy to follow language. High level of influence and mediation skills; can facilitate bringing people from different perspectives to consensus. Can represent Getinge at outside meetings and working groups. A results focused, people oriented leader, who can create an environment where people can grow/develop, can “challenge” people towards the right direction. Contributes to team effort by accomplishing related duties as requested.$170k - $210k
20% international travel
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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.
