ORGENTEC Diagnostika GmbH is the global market leader in the development and production of test systems for the diagnosis of infectious and autoimmune diseases. As part of the Sebia Group, headquartered in Lisses/France, ORGENTEC supplies medical laboratories in over 100 countries with highly specialised and innovative devices and test kits. Our company is characterised by steady and sustainable growth in an internationally oriented, future-oriented business field.
To strengthen our team at the Mainz site, we are looking for a
Quality Design Manager
(M/W/D)

Skills:

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field. A Master’s degree is a plus
• Minimum of 3 years of experience in design quality or quality assurance in the medical device industry
• At least 2 years of experience in a managerial or leadership role, managing a team of quality professional

• Oversee the implementation and management of the design control process for medical devices, ensuring compliance with FDA (21 CFR 820) and ISO 13485 standards
• Collaborate with respective Departments to ensure product design changes and modifications are developed with quality and regulatory compliance in mind
• Contribute to risk management activities for new products and design changes using tools such as FMEA (Failure Modes and Effects Analysis), risk assessments, and fault tree analysis in alignment with Product Risk Manager
• Oversee design validation and verification testing to ensure product performance meets safety and regulatory standards
• Work with cross-functional teams to ensure quality concerns are addressed early in the design process and product risks are mitigated
• Providing guidance on quality standards throughout the product development cycle
• Manage and support internal and external audits related to design controls and quality assurance activities, ensuring the company is prepared for regulatory
• Provide training and guidance to internal teams on design control, quality assurance practices, and regulatory requirements

Skills:

• Bachelor’s degree in Engineering, Quality, Life Sciences, or a related field. A Master’s degree is a plus
• Minimum of 3 years of experience in design quality or quality assurance in the medical device industry
• At least 2 years of experience in a managerial or leadership role, managing a team of quality professionals

Benefits :

• Permanent employment contract
• A crisis-proof job with an attractive income
• Annual salary review
• Flexible working hours
• Individualised employee development and training
• Attractive package of health and social benefits (e.g. subsidised computer glasses, flu vaccination, employer contribution of 30% to private pension scheme)
• Employer subsidy for the canteen, free drinks
• Crèche and kindergarten allowance (max. €200)
• Employee discounts with well-known brands
• Anniversary bonus
• Car park directly at the company