Senior Quality Engineer

Konstanz; Germany,

Aspire Life Sciences partnered with an innovative dental MedTech company specialising in high-performance zirconia dental implants. The organisation combined cutting-edge materials science with biological dentistry principles to develop advanced implant solutions that supported modern, patient-centric dental treatments. With a strong international presence, its products were distributed globally and recognised for their contribution to next-generation restorative dentistry.

The Assignment

We successfully supported the search for a Senior Quality Engineer who joined the organisation to take ownership of key quality and regulatory activities across the business.

The successful candidate played a pivotal role in maintaining and enhancing the Quality Management System while supporting product development, supplier quality management, and compliance with global medical device regulations. This was a hands-on, high-impact position that required strong technical expertise and the ability to embed quality principles throughout a growing MedTech organisation.

Key Responsibilities

  • Led quality and regulatory compliance activities, with a primary focus on quality engineering.
  • Owned validation and verification activities, including Computer System Validation (CSV).
  • Conducted risk analyses and drove risk management processes across products, processes, and operations.
  • Developed and managed inspection planning and quality control strategies.
  • Led supplier quality and supplier development initiatives to ensure consistent product quality and regulatory compliance.
  • Supported product development projects from a quality and compliance perspective.
  • Managed CAPAs and non-conformities, ensuring effective investigation, resolution, and continuous improvement.
  • Planned and conducted internal and supplier audits while supporting preparation for external audits and inspections.
  • Developed and delivered training programmes related to quality systems, processes, and regulatory requirements.
  • Maintained and continuously improved the Quality Management System in accordance with ISO 13485, MDR, and MDSAP requirements.
  • Supported key quality processes including change management, document control, CAPA management, auditing, and employee training.
  • Assisted in preparing regulatory documentation to support market approvals and ongoing compliance activities.
  • Contributed to technical and development documentation throughout the product lifecycle.
  • Promoted and embedded a strong culture of quality across the organisation.

Why This Opportunity Stood Out

  • The opportunity to join a fast-growing and innovative dental MedTech company at the forefront of ceramic implant technology.
  • A collaborative and modern working environment characterised by flat hierarchies and a strong team culture.
  • Flexible working arrangements, including home-office options.
  • The chance to shape and enhance quality processes within a scaling international medical device business.
  • Access to employee wellbeing initiatives and regular company events, supporting both professional and personal development.