Hobson Prior is seeking a highly skilled and experienced Quality Manager to join their team. The Quality Manager will be responsible for ensuring that all products meet the highest standards of quality, safety, and regulatory compliance. This role requires a deep understanding of quality management systems, regulatory requirements, and industry standards specific to medical devices. The ideal candidate will have a strong background in quality assurance, exceptional leadership skills, and a commitment to continuous improvement.
Please note that to be considered for this role you must have the right to work in this location.

QUALIFICATIONS AND REQUIREMENTS:

• Bachelor’s degree in Engineering, Life Sciences, or a related field; advanced degree preferred.
• Experience in quality management within the medical device industry.
• In-depth knowledge of ISO 13485, FDA regulations, CE Mark requirements, and other relevant standards.
• Proven experience in developing and implementing Quality Management Systems (QMS).
• Fluent German and English
• Required to work full-time on-site in Tuttlingen
  For more information, please contact Toby Shelton.

• Develop and maintain the Quality Management System (QMS) in accordance with ISO 13485 and MDSAP
• Ensure compliance with all applicable regulatory requirements, including, CE Mark, and other international regulations.
• Conduct regular audits, inspections, and reviews of production processes to identify areas for improvement and ensure compliance with quality standards.
• Collaborate with cross-functional teams, including R&D, manufacturing, and supply chain, to develop and implement quality improvement initiatives.
• Oversee the investigation and resolution of product quality issues, including non-conformances, CAPAs, and customer complaints.
• Develop and maintain quality documentation, including standard operating procedures (SOPs), work instructions, and quality records.
• Monitor and analyse key quality metrics, generating reports and presenting findings to senior management.
• Stay up-to-date with industry trends, best practices, and regulatory changes to ensure continuous improvement and compliance.
• Foster a culture of quality and continuous improvement throughout the organisation.