Quality Engineer (12‑month contract)

About the role

This 12‑month contract position supports the administration and continuous improvement of the quality management system at a manufacturing site. The Quality Engineer ensures compliance with multiple regulatory standards and leads key quality initiatives.

Key responsibilities

• Administer the QMS to meet ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMP, ISO 17025, ISO 11137/11135 requirements.
• Lead complaint and CAPA investigations, supplier quality improvement, and continuous‑improvement projects using statistical techniques.
• Coordinate and mentor Quality Technicians, oversee product and report pre‑reviews, and execute releases for non‑conforming runs.
• Perform internal audits, manage remediation of audit findings, and develop or revise quality system policies and procedures.
• Analyze collected data, recommend process changes, monitor performance metrics, and provide training on quality principles.
• Collaborate with cross‑functional teams on calibration, maintenance, training, document control, change control, risk management, and other quality system programs.

Required profile

• Bachelor’s degree in Engineering, Science, or a related field.
• Experience with ISO 9001, ISO 13485, FDA 21 CFR Part 820/211, EU GMP, ISO 17025, ISO 11137/11135.
• Proven ability to lead CAPA investigations, internal audits, and continuous‑improvement initiatives.
• Strong analytical skills and familiarity with statistical analysis techniques.

Required skills

• Quality Management Systems (QMS) implementation and maintenance.
• Regulatory standards: ISO 9001, ISO 13485, FDA 21 CFR 820/211, EU GMP, ISO 17025, ISO 11137, ISO 11135.
• CAPA and complaint handling.
• Statistical analysis and data‑driven process improvement.
• Internal auditing and corrective‑action management.

What we offer

• 12‑month contract with exposure to a global quality system.
• Opportunities to lead cross‑functional quality projects.
• Professional development in a regulated manufacturing environment.