Quality Assurance Engineer – Post‑Market Surveillance

About the role

The Quality Assurance Engineer will lead post‑marketing surveillance activities, analysing trends, investigating complaints and feeding insights back to R&D and marketing. The role supports the CAPA system and ensures product performance is communicated across the organization and to external customers.

Key responsibilities

• Analyse customer complaints and post‑marketing data to identify patterns and trends.
• Initiate formal trend investigations, prepare trend reports and work with cross‑functional teams.
• Present product performance findings to management committees and design teams.
• Review and approve investigations of varying complexity, providing guidance to investigators.
• Act as Subject Matter Expert, mentor junior engineers and drive continuous‑improvement initiatives.
• Supervise a small team of engineers, handling performance management and coaching.

Required profile

• Bachelor’s or Licentiate degree in Chemical, Mechanical, Mechatronics, Materials, Biomedical Engineering or related field.
• 4+ years experience in a regulated medical environment, preferably in post‑market quality.
• Proven experience supervising staff.
• English proficiency at 85‑95% level.

Required skills

• Problem‑solving techniques.
• Critical thinking.
• Statistical analysis tools.