Quality Engineer

About the role

We are seeking a motivated Quality Engineer to join our Quality Assurance team. The role provides day‑to‑day engineering support for manufacturing operations and projects, ensuring compliance with GMP, regulatory requirements and internal procedures.

Key responsibilities

• Provide quality engineering support to manufacturing, investigate deviations, non‑conformances and customer complaints, and drive CAPA implementation.
• Develop, review and execute validation documentation (IQ, OQ, PQ, process and cleaning validation) and support equipment, utility and process qualification.
• Act as the Quality representative on cross‑functional project teams, reviewing project documentation and ensuring quality requirements are integrated throughout the lifecycle.
• Support change control activities, monitor quality metrics and identify continuous‑improvement opportunities.
• Ensure compliance with GMP, ISO and other regulatory standards, and assist with internal and external audits.

Required profile

• Bachelor’s degree in Engineering, Science, Quality or a related discipline.
• 3–5 years of experience in a regulated manufacturing environment (pharma, medical device or biotechnology).
• Hands‑on experience in both quality operations and validation activities.
• Proven project experience supporting new equipment, process improvements or capital projects.

Required skills

• Strong knowledge of GMP and quality management systems.
• Experience with validation lifecycle principles (IQ, OQ, PQ).
• Proficiency in CAPA, deviation handling, change control and risk management.
• Familiarity with FDA, EU GMP, ISO 13485 and ISO 9001 requirements.
• Audit experience (internal and external) and technical writing/documentation skills.
• Lean, Six Sigma or similar continuous‑improvement methodologies.