R&D Technical Development Quality Lead

R&D Technical Development Quality Lead (M/W/D) Responsibilities

• Provide quality leadership and strategic guidance for global medical device and combination product development projects within a matrix organization.
• Act as QA representative for Global Device and Packaging Development (GDPD) project teams and contribute to project governance meetings and development milestones.
• Ensure quality oversight throughout the device development lifecycle, including risk assessments, quality strategies, and compliance activities.
• Support cross‑functional teams in resolving quality‑related topics and ensure alignment with internal QA strategies and external regulatory requirements.
• Review and approve technical documentation, quality records, deviations, and change‑related assessments within medical device development projects.
• Support the preparation and hosting of Notified Body inspections and regulatory audits.
• Contribute to the development and maintenance of Quality Management System (QMS) documentation, including SOPs, work instructions, and quality agreements.
• Support the assessment of new medical device regulations and standards and coordinate related implementation activities.
• Lead and contribute to global quality initiatives and continuous improvement projects.
• Collaborate closely with internal stakeholders including Device Development, R&D, Regulatory Affairs, Manufacturing, and external partners.

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 5+ years of experience in Quality Assurance, preferably within medical devices, combination products, or drug delivery systems.
• Strong knowledge of medical device quality standards and regulations, including ISO 13485, ISO 14971, EU MDR, and FDA device requirements.
• Proven experience in medical device development, design controls, risk management, and technical documentation.
• Experience supporting or participating in Notified Body inspections and regulatory audits.
• Demonstrated ability to lead cross‑functional teams and work effectively in a global matrix organization.
• Experience with Quality Management Systems (QMS), deviation management, CAPA, change control, and electronic quality systems (e.g., Track Wise).
• Strong communication and stakeholder management skills.
• Fluent English required (written and spoken); additional local language skills are a plus.