Manager Quality & Regulatory Affairs (f/m/d)

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Manager Quality & Regulatory Affairs (f/m/d)

Apply locations Weinheim time type Full time posted on Posted 5 Days Ago job requisition id R_00083000

Working at Freudenberg: We will wow your world!

Responsibilities:

• Maintenance and further development of our quality management system in compliance with all relevant legal and normative requirements (ISO 13485, MDR, FDA and specific customer requirements)

• Planning and coordination / execution of internal and external audits and certifications including the coordination of corrective and preventive actions (CAPA)

• Carrying out risk analyses according to ISO 14971 in the team as FMEA moderator

• Processing of regulatory affairs and product stewardship for the products of the Healthcare Division of Freudenberg Performance Materials

• Quality-related support of change processes and the implementation of process optimizations, including any necessary qualification/validation activities, also as validation manager

• Preparation and execution of training courses to ensure and raise awareness of quality and hygiene-related topics

• Collaboration in national and international projects to ensure quality standards

• Quality-related support and safeguarding of business relationships with external partners such as customers, suppliers and service providers

• Maintaining quality-related documentation and supporting the creation of quality reports and KPIs

Qualifications:

• Completed studies in the field of medical technology, quality management, engineering or a comparable qualification

• First experience in quality management, especially in the area of ISO 13485, MDR, FDA and ISO 14971 and validation activities

• Initial experience with internal and external audits and in dealing with authorities desirable

• Structured, solution-oriented way of working with high problem-solving skills

• Convincing and assertive personality with strong teamwork skills

• Very good written and spoken German and English skills

• Confident handling of MS Office and QMS software

The Freudenberg Group is an equal opportunity employer that is committed to diversity and inclusion. Employment opportunities are available to all applicants and associates without regard to race, color, religion, creed, gender (including pregnancy, childbirth, breastfeeding, or related medical conditions), gender identity or expression, national origin, ancestry, age, mental or physical disability, genetic information, marital status, familial status, sexual orientation, protected military or veteran status, or any other characteristic protected by applicable law.

Freudenberg Performance Materials GmbH & Co. KG

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