R&D Quality Lead Medical Devices; m​/f​/d

For a leading pharmaceutical company, we are looking for a qualified candidate for a temporary assignment.

Start Date:

01 August 2026

End Date: 30 June 2027 (extension possible)

• Provide quality leadership and oversight for global medical device and combination product development projects.
• Partner with cross‑functional teams to ensure compliance with regulatory requirements and internal quality standards throughout the development lifecycle.
• Support project strategy development by contributing to risk assessments, quality planning activities, and mitigation strategies.
• Review and approve technical documentation, quality records, change controls, deviations, and project‑related deliverables.
• Assess the quality impact of design, manufacturing, and process changes and support implementation of appropriate actions.
• Support audits, inspections, and interactions with regulatory authorities and external partners.
• Drive continuous improvement initiatives and contribute to the development and maintenance of Quality Management System processes and documentation.

• Bachelor's degree with at least 10 years, or Master's degree with at least 5 years of relevant experience in Quality Assurance, Quality Control, Medical Device Development, or related functions within a regulated pharmaceutical or medical device environment.
• Solid understanding of quality systems, regulatory requirements, and industry standards applicable to medical devices, including MDR, ISO 13485, and related quality frameworks.
• Proven experience providing quality oversight for development projects, including technical documentation review, risk assessments, change management, and validation activities.
• Experience supporting audits, inspections, and interactions with regulatory authorities and/or Notified Bodies within a highly regulated environment.
• Strong background in cross‑functional collaboration and the ability to influence project teams within matrix organizations while balancing quality, compliance, and business objectives.
• Experience in medical device, combination product, or drug delivery system development, with the ability to apply risk‑based decision‑making and strategic quality thinking throughout the product lifecycle.
• Fluent English (written and spoken) is required;
  German language skills are considered a strong advantage.