QA Manager Medical Device Development (m/f/d)

QA Manager Medical Device Development

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 1,600 employees in 36 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 execute and guide teams through Design Control requirements
• You support transfer to manufacturing
• You support preclinical and clinical planning and readiness
• You support Regulatory submissions
• You effectively manage project timelines as defined by department, project team, and corporate objectives.
• You manage the development risk process and the usability process
• You Guide and provide input to risk management and usability activities throughout all stages of the device development process
• You manage the risk management plan, risk file and risk report for new products
• You support R&D related audits, both internal and external
• You support approval of R&D vendors/suppliers
• You support R&D related SOP creation and maintenance
• You support R&D related NCRs/CAPAs
• You assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates/modifications related to applicable regulations (ISO, Ministries of Health (FDA, EMA, Health Canada, TGA, ANVISA, etc.))
• You facilitate and support harmonization initiates within the R&D group
•  You facilitate and support projects to improve R&D compliance and operational efficiencies
• You support internal and external audit activities
• You assist in ensuring applicability of current quality policies, procedures and objectives by keeping informed of the latest updates related to applicable regulations
• You provide support to other regulatory staff as needed and perform duties and assignments as required. Communicate and raise questions/issues to the attention of regulatory management

WHAT WE EXPECT FROM YOU:

• Academic degree in a natural science discipline (pharmacy, biology, chemistry)
• Minimum 3 years relevant medical device development experience including quality
• Certification(s) (ASQ Certified Quality Manager; Certified Quality Engineer, or Certified Quality Auditor) are welcome but not required
• Proficiency in all MS Office applications
• Organizational skills, ability to independently prioritize work and detail orientation
• Strong verbal and written communication skills in German and English
• Knowledge of regulatory requirements and standards for a medical device organization (i.e. 21CFR820, ISO 13485, ISO 14971, IEC 62304, ICH guidelines)
• Experience with FDA, European agency regulations, cGMP regulations, and Quality Management software ist highly preferred
• Demonstrated leadership skills and experience as a team lead
• Excellent Interpersonal skills
• Ability to work effectively in a global, matrix environment 

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 Employee Assistance Program.