QA Manager Medical Device Development (m/f/d), R&D Quality - #2113203

Merz Aesthetics is an international company in the field of aesthetic medicine. Our broad product portfolio is synonymous with top quality in each of their categories and is highly regarded by healthcare professionals worldwide. As Merz Aesthetics, we are part of the Merz Group with our EMEA headquarters located in Frankfurt am Main, Germany. Our global head office is located in Raleigh, North Carolina, USA. Every day, more than 2,500 employees in 26 countries are committed to restoring and maintaining the skin's beauty. Would you like to become part of our success story? Then join Merz Aesthetics!

The following responsibilities are awaiting you:

• You lead R&D project teams through Design Control requirements, ensuring compliance across development phases, supporting preclinical and clinical planning, contributing to regulatory submissions, and facilitating smooth transfer to manufacturing.
• You manage risk and usability processes, guiding activities, documentation, and cross-functional input throughout all stages of the product development lifecycle, including maintaining the risk management plan, risk file, and usability strategies.
• You support audits and inspections, preparing for and participating in internal and external audits, and addressing findings in collaboration with relevant stakeholders.
• You ensure R&D quality system compliance, supporting the creation and maintenance of SOPs, managing NCRs and CAPAs, qualifying vendors and suppliers, and aligning practices with applicable standards and regulations (e.g., ISO, FDA, EMA, Health Canada).
• You drive quality and operational improvements, leading initiatives to enhance efficiency, harmonize processes, and strengthen the R&D Quality Management System.
• You collaborate across departments, providing support to quality colleagues, escalating issues appropriately, and performing additional tasks as needed to support overall business and company objectives.
  
  

What we expect from you:

• You hold a higher university degree (Master’s preferred) in a relevant scientific, engineering, or technical field, with a strong understanding of medical device development.
• You bring at least 5 years of experience in the medical device industry, with proven involvement in product development, quality systems, and regulatory compliance.
• You have a solid grasp of regulatory frameworks and standards, including MDSAP, 21 CFR 820, ISO 13485, ISO 14971, IEC 62304, and EU MDR, and are experienced in ensuring quality compliance throughout design and manufacturing processes.
• You ideally hold or are pursuing certifications such as ASQ Certified Quality Manager, Certified Quality Engineer, or Certified Quality Auditor.
• You are proficient in both electronic Quality Management Systems (e.g., MasterControl, SAP, Oracle) and MS Office applications, supporting effective documentation and communication.
• You demonstrate strong organizational and communication skills, with the ability to manage priorities independently, maintain attention to detail, and clearly convey technical concepts across functions and cultures.
• You have proven leadership and interpersonal abilities, including experience leading teams or cross-functional initiatives, fostering collaboration, and resolving challenges effectively.
• You thrive in a global, matrixed environment, showing adaptability, cultural awareness, and a proactive approach to achieving shared goals.
  
  

What you can expect from us:

Putting people first: You can expect to find an open work culture with flat hierarchies and short decision-making paths at Merz Aesthetics. You will collaborate with colleagues from all around the globe. And if life takes an unexpected turn and you need help or advice, then you can always rely on our different internal and external support systems.

Family and work: Our employees should be able to reconcile their family and work commitments. That’s why you’ll find, for example, company day care centers at our locations. In the EMEA region, we have been awarded the “Top Employer” and “Great Place to Work” certifications for our outstanding HR policies and work culture.

Work-life harmony: Our time is precious; our daily routines individual. To help you reconcile work and leisure time with their conflicting demands, we have adopted contemporary flexible working time models. We offer you flex-working time and mobile working. Our employees also benefit from generous arrangements for annual leave.

Ongoing training: Your personal and professional development is the key to success for us. To foster this, we conduct regular development discussions and facilitate a wide range of management and specialist training courses, soft skills courses, e-learning courses, language courses and coaching sessions.

Find out more about our benefits at https://careers.merz-aesthetics.com.

We look forward to your application!