Director of International Post Market Quality, Infusion
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
Our vision for Quality at BD
In our Quality team, we collaborate on a large scale, focusing on making sure everything is accurate, effective and efficient to bring the highest-quality and most competitive products and services to our customers and their patients
About the role
Reporting to the VP Quality EMEA, the Director of Post Market Quality will lead post market activity for our infusion products (pumps and disposables) in all markets Outside of US.
You will lead the team and be responsible for project managing day-to-day compliance related to product risk assessments and outcomes, notification and evaluation of incidents, competent authority inquiries and follow up, field actions and Quality Management System process integration and alignment.
Other key responsibilities will include:
- Owning the resolution of outstanding and current post-market Quality issues
- Identifying and coordinating the implementation of optimization opportunities
- Providing guidance to the end-to-end complaints process, including regulatory reporting
- Accountability for relationships with authorities, ensuring required results and timelines are met
- Coordinating activities relating to the Situation Analysis/Health Risk Assessment/ Field Action Committee processes to ensure appropriate responsibilities, accountabilities, and outcomes for the product portfolio; collaborating with the EMEA Center of Excellence for the execution of field actions
We are looking for candidates with strong post-market experience in the healthcare industry or medical device manufacturing in a sophisticated matrix structure. The ideal candidate has demonstrated experience working with competent authorities, notified bodies and other regulatory agencies.
A strong leader, you show an ability to drive the performance and develop your team members. You are a solution seeker and always focus on process improvement across multiple projects and activities in various fields thanks to your high levels of planning and organisational skills. Strong interpersonal skills enable you to optimally present information to management, groups and/or customers as well as work through influencing others.
Click on Apply if this sounds like you!
Why join us?
A career at BD means that you are part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here you can fulfill your life’s purpose through the work that you do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
Primary Work LocationCHE Eysins - Business Park Terre-Bonne
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