At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make.
Join our team as
Expert Component Qualification (QM/RA) (f/m/d)
DEU-Heidenheim
As Expert Component Qualification (QM/RA) (f/m/d) for Procedure Packs, you will play a crucial role in ensuring our products meet regulatory and quality standards across global markets. You will serve as a key interface between development, marketing and suppliers. If you have a passion for Regulatory and Quality in the medical device field, this role offers you the opportunity to make a tangible impact on patient safety and innovation.
Responsibilities:
* Manage Quality and Regulatory Affairs topics related to components for procedure packs in compliance with internal policies and external regulations
* Support development and marketing teams regarding component qualification
* Qualify suppliers and maintain up-to-date component documentation
* Develop, maintain, and deliver training for internal processes and work instructions
* Support internal and external audits, CAPAs, vigilance, and recall activities
* Conducting internal trainings on component qualification issues
Qualifications:
* Completed degree in natural sciences, medicine, or a comparable technical discipline; alternatively, a technical qualification with relevant professional experience
* Formal training or hands-on experience in Regulatory Affairs is beneficial
* Solid understanding of Quality and Regulatory Affairs in the medical device or pharmaceutical industry
* Strong intercultural communication skills
* Analytical mindset with excellent problem-solving capabilities
* Proficient in both English and German (written and spoken)
Benefits:
* Flexible working conditions, such as flexible working hours and mobile working
* International Mobile Working
* Attractive ways of combining work and family life, e.g. childcare subsidy
* 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
* Company pension plan with attractive employer contribution incl. matching model for deferred compensation
* Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
* Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
* Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
* Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform, Job Bike Leasing