Operational Quality Assurance Engineer

About the role

The Operational Quality Assurance Engineer ensures that manufacturing, engineering and support processes meet Quality Management System, regulatory and customer requirements. The role drives product quality, compliance and continuous improvement through oversight, investigations and cross‑functional collaboration.

Key responsibilities

• Provide QA support to Operations, Engineering, Supply Chain, QC, Logistics and Supplier Quality to ensure compliance with customer, regulatory and QMS requirements.
• Lead investigations, deviations, change controls and quality improvement initiatives to implement sustainable corrective actions.
• Act as Subject Matter Expert for product release activities, ensuring releases meet quality and business needs.
• Support validation and qualification activities and oversee process and product changes.
• Monitor Quality KPIs, communicate trends and drive continuous improvement using Danaher Business System tools.

Required profile

• Bachelor's degree in Science, Engineering, Biotechnology, Pharmacy or related field.
• Minimum 3 years of QA, Quality Engineering or Quality Systems experience in regulated manufacturing (Medical Device, Biopharma, Biotechnology).
• Professional proficiency in English and French.
• Ability to work in manufacturing, laboratory, warehouse and office environments and wear required PPE.

Required skills

• Working knowledge of ISO 9001 and GMP requirements.
• Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise or MasterControl.
• Experience managing deviations, CAPA, change controls, investigations and validation/qualification records.