Quality Engineer – Medical Device Manufacturing

About the role

We are seeking a Quality Engineer to support validation, advanced quality, risk management, change control and design development for our dental implant and digital dentistry product lines. The role ensures compliance with our Quality Management System, ISO standards and FDA regulations while driving continuous improvement.

Key responsibilities

• Plan, execute and report equipment and process validations.
• Develop and maintain inspection and validation techniques to verify product requirements early in production.
• Support internal and external audits, including preparation for regulatory inspections.
• Lead quality investigations, root‑cause analysis and propose corrective actions.
• Maintain and improve the Risk Management and Change Management programs.
• Collaborate with cross‑functional teams to develop metrics and drive quality performance.
• Provide training on quality and compliance concepts.

Required profile

• Bachelor’s degree in engineering, quality or a related manufacturing field (preferred).
• Minimum 3 years of quality control or assurance experience in medical device manufacturing.
• Proven ability to work with multidisciplinary teams on projects, investigations and training.
• Strong documentation skills and familiarity with ISO and FDA quality system requirements.

Required skills

• Equipment and process validation.
• Risk management and mitigation.
• Change control management.
• Root‑cause analysis and corrective action implementation.
• ISO 13485 / ISO 9001 standards.
• FDA Quality System Regulation (QSR) compliance.
• Audit planning and execution.