Expert Component Qualification (QM/RA) (f/m/d)

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