Senior Quality Engineer

About the role

We are seeking a Senior Quality Engineer to lead investigations of non‑conformances, drive corrective and preventive actions, and ensure our medical‑device products meet the highest quality standards. The role works closely with Engineering, Production and cross‑functional teams in a regulated manufacturing environment.

Key responsibilities

• Lead root‑cause investigations of non‑conforming products and implement corrective and preventive actions.
• Collaborate with Engineering, Production and other departments to guarantee product and process compliance with quality requirements.
• Support internal and external audits by preparing documentation, participating in audit activities and addressing observations.
• Escalate quality concerns to Quality Assurance and Engineering leadership and assist in resolution.
• Manage containment activities, including identification, segregation, documentation and reconciliation of non‑conforming items.
• Monitor, analyze and trend quality data to identify risks, recurring issues and improvement opportunities.
• Ensure compliance with the Quality Management System and applicable regulatory requirements such as 21 CFR Part 820, ISO 13485 and MDSAP.
• Apply statistical analysis and risk‑management tools, including Failure Mode and Effects Analysis (FMEA), to support continuous improvement.

Required profile

• Bachelor’s degree in Engineering or a related technical field.
• Minimum 3 years of experience in Quality Engineering within a regulated medical‑device manufacturing environment.
• Working knowledge of 21 CFR Part 820, ISO 13485 and the Medical Device Single Audit Program (MDSAP).
• Advanced proficiency in written and spoken English.

Required skills

• Statistical analysis.
• Risk‑management tools.
• Failure Mode and Effects Analysis (FMEA).
• Regulatory standards: 21 CFR Part 820, ISO 13485, MDSAP.