Director of Quality

Director, Quality Engineer (NPD)

Base Salary: €120,000 - €149,000 + Bonus + Equity

Overview:

This leadership role oversees a team of Design Quality Engineers, ensuring design controls and risk management processes are effectively implemented across new product development (NPD) projects. The position ensures alignment with global regulatory requirements and quality standards, working cross-functionally to support compliance and successful product launches.

Key Responsibilities:

• Lead and develop a team of Design Quality Engineers at a European R&D site.
• Ensure robust application of design controls and risk management across the product lifecycle.
• Oversee design verification, validation, and documentation for global regulatory approvals (e.g. FDA, CE, ISO).
• Collaborate with teams across R&D, Regulatory, Manufacturing, and Usability to ensure compliance and quality.
• Maintain awareness of evolving regulatory standards and drive continuous improvement initiatives.
• Support global alignment of quality engineering practices in NPD.

Qualifications:

• Bachelor's degree in Engineering, Quality, or related field (Master’s preferred).
• 10+ years in regulated industries (e.g., medical devices, pharma), with 3+ years in a leadership role.
• Strong expertise in design controls, risk management (ISO 13485, 21 CFR 820), and product development.
• Experience with global regulatory submissions and audits.
• Excellent communication, team leadership, and cross-functional collaboration skills.
• Preferred: CQE, Six Sigma, Lean, or RAC certification.