Quality Engineer

About the role

Trelleborg Medical Solutions seeks a Quality Engineer to support manufacturing processes within a regulated medical‑device environment. The role focuses on developing and maintaining a Quality Management System that meets FDA and ISO requirements while driving cost‑effective, lean manufacturing practices.

Key responsibilities

• Develop, administer, and continuously improve the Quality System in compliance with FDA 21 CFR 820 and ISO 13485/9001.
• Support internal and external audits, customer complaints, non‑conforming events, and CAPA activities.
• Perform root‑cause investigations, statistical and capability analyses, and trend reporting for management review.
• Author and execute Quality Plans, equipment qualifications, process, cleaning, and software validations, and pFMEA documentation.
• Collaborate with Engineering, Manufacturing, NPD, and Inspection teams to define design, tooling, and validation requirements.
• Communicate with customers on complaints, process changes, and specification clarifications.
• Conduct gauge R&R studies and develop measurement system programs.

Required profile

• Engineering degree (e.g., Mechanical, Electrical, or related).
• Minimum 4 years of experience in medical‑device manufacturing.
• Strong knowledge of ISO 9001, ISO 13485, and FDA 21 CFR 820 regulations.
• Proficiency in English (B2+ level).
• ASQ Certified Quality Engineer or equivalent certification is desired.

Required skills

• ISO 9001
• ISO 13485
• FDA 21 CFR 820
• CAPA management
• Root‑cause analysis
• Statistical and capability analysis
• Gauge R&R / measurement system analysis
• Equipment qualification
• Process, cleaning, and software validation
• pFMEA
• Lean manufacturing principles

What we offer

• Opportunity to work on cutting‑edge medical‑device projects.
• Collaborative environment with cross‑functional teams.
• Professional development and certification support.