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.S. 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.