Senior Quality Systems Expert (m/f/d)
Your tasks:
- Global responsibility for all quality system processes supporting product portfolio.
- Make recommendations for quality system advancements that ensure quality assurance activities are directed towards process improvement, continuous improvement, preventative and corrective actions, cost effectiveness of processes, systems, and procedures.
- Develop metrics to monitor progress and effectiveness of actions taken for reporting to Sr. Management.
- Lead global quality reviews for product portfolio including collecting and presenting data to Senior Leadership. Monitor any actions coming out of meeting.
- Liaison for internal audits, external audits and supplier audits to support product portfolio.
- Where appropriate, coordinate changes to corporate procedures with site personnel to ensure changes are implemented and training is conducted at all levels of the organization.
- Support projects including planning, preparing and executing global harmonization activities to ensure achievement of business synergies
- Develop and maintain quality systems training to ensure understanding of compliance requirements throughout the organization. Develop programs to ensure continuous state of inspection readiness.
- Keep abreast of industry trends with respect to matters relating to cGMP, QSR, ISO requirements.
Your profile:
- B.Sc. in technical or clinical discipline or equivalent. CQA, CQE and Six Sigma experience is a plus.
- Minimum of six years related Quality Assurance experience in the Medical Device Industry including both domestic and international.
- Detailed regulatory knowledge (FDA/21CFR Parts 803, 806, 820; Medical Device Directive; Canadian Medical Device Regulations, ISO 13485)
- Significant FDA and notified body inspection direct experience preferred.
- English fluent as a must (presenting, writing, reading)
Our offer to you
There is a lot for you to discover at Fresenius, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:
- The opportunity to work on a mobile basis
- Whether in front of or behind the scenes - you will help to make better and better medicine available to more and more people around the world
- Individual opportunities for self-determined career planning and professional development
- A corporate culture in which there is enough room for innovative thinking - to find the best, not the fastest, solution together
- A large number of committed people with a wide range of skills, talents and experience
- The benefits of a successful global corporation with the collegial culture of a medium-sized company
Please note that in addition to your CV, please also submit your references and certificates and, ideally, a cover letter before completing your application.
Career with a purpose
Inclusion and diversity
Stability
Learning and development
Local benefits
Work-life balance
At a glance
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We care about sharing information and experiences as this helps us learn from our mistakes and each other. We tackle challenges together by reaching out to colleagues both near and far. We communicate openly.
We challenge the status quo and show interest in what happens around us. We ask questions to clearly understand what needs to be done and take ownership of the results.
We live up to our own expectations, show respect and lead by example. We act with integrity and in line with our standards every day.
We make things better today than they were yesterday. We pitch ideas on how to improve and innovate.
What we stand for
Empowering people. Advancing care. Inspiring with our purpose and values.
Everything we do here is about making people’s lives better, simpler and longer. Our teams work cross-functionally to reproduce the complex function of kidneys with treatments that meet high quality standards, improve clinical outcomes, and are sustainable and compliant. Internally, we promote diversity and inclusion as key elements of a positive, supportive work environment. Our values support our mission to develop high quality products and services, to have a positive impact on the health and wellbeing of patients, and to lead Fresenius Medical Care towards a successful, sustainable future.