Quality Engineer

Job Description

As a Quality Engineer in a manufacturing environment, you will play a key role in ensuring products are manufactured in accordance with internal quality standards, regulatory requirements, and the company’s commitment to patient safety and product excellence.

The role involves close collaboration with Manufacturing, Operations, R&D, and Supply Chain teams, leading quality improvements and supporting continuous improvement initiatives on the production floor.

The role includes, but is not limited to:

• Provide quality engineering support to manufacturing and engineering activities.
• Support manufacturing, engineering, and validation activities, including training, review and approval of documentation, work instructions, and SOPs, as well as support for risk assessments to ensure compliance with regulatory and quality system requirements.
• Lead and support investigations of nonconformances, deviations, and CAPAs, including root cause analysis and implementation of corrective and preventive actions.
• Collaborate with cross-functional teams to identify, assess, and mitigate quality risks within manufacturing processes.
• Support internal and external audits, including preparation, participation, and follow-up on findings.
• Lead continuous improvement initiatives using quality methodologies and Lean tools.
• Ensure effective implementation and monitoring of process controls and quality metrics.
• Support change management processes, including identification and implementation of relevant requirements when needed.
• Update procedures to align with global standards and requirements.
• Participate in management reviews and quality metrics reporting.

• Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related field.
• At least 7 years of experience in Quality within a regulated industry (medical devices, pharmaceuticals, or similar).
• Familiarity with quality systems and regulatory requirements (e.g., ISO 13485, FDA QMSR, MDR).
• Strong analytical skills and problem-solving abilities.
• Ability to work effectively in a dynamic manufacturing environment and collaborate with multiple interfaces.
• High level of English proficiency – written and spoken.
• Hands-on experience managing ECOs, nonconformances, CAPA, and root cause analysis tools.
• Familiarity with statistical tools and data analysis.
• Experience supporting audits and regulatory inspections.
• Knowledge of Lean, Six Sigma, or continuous improvement methodologies – an advantage.
  

temporary position until September–October.