QA Engineer for Life Sciences & Biotech

Radiometer; Schweiz; On-site; CHF 90,000 - 150,000; Full time

Job summary

Cytiva, a Danaher operating company, seeks an Operational Quality Assurance Engineer to ensure manufacturing, engineering, and support processes comply with QMS, regulatory, and customer requirements. You will drive product quality, support investigations, and partner cross-functionally to secure timely release of compliant products.

The role reports to the QA Operations Team Leader within the Quality and Regulatory Affairs organization, located in Grens, Switzerland, and is an on-site position.

Qualifications

• Bachelor's degree in Science, Engineering, Biotechnology, Pharmacy, Life Sciences, or related technical field.
• Minimum 3 years of Quality Assurance, Quality Engineering, or Quality Systems experience in regulated manufacturing environments.
• Working knowledge of ISO 9001 and/or GMP requirements.
• Experience managing quality records (deviations, CAPA, change controls, investigations) in an electronic QMS.

Responsibilities

• Provide QA support to Operations, Engineering, Supply Chain, QC, Logistics, and Supplier Quality to ensure regulatory and QMS compliance.
• Lead investigations, deviations, change controls, and quality improvement initiatives.
• Serve as SME for product release activities and ensure releases meet quality requirements.
• Support validation and qualification activities and oversee changes.
• Monitor Quality KPIs and support DBS-driven continuous improvement.
• Foster cross-functional partnerships to promote quality culture and operational excellence.

Skills

Quality Assurance

Quality Engineering

Regulatory compliance

GMP knowledge

DBS knowledge

Cross-functional collaboration

Education

Bachelor's degree in Science, Engineering, Biotechnology, Pharmacy, Life Sciences, or related technical field

Tools

Veeva

TrackWise

MasterControl

Job description

Cytiva, a Danaher operating company, seeks an Operational Quality Assurance Engineer to ensure manufacturing, engineering, and support processes comply with QMS, regulatory, and customer requirements. You will drive product quality, support investigations, and partner cross-functionally to secure timely release of compliant products.

The role reports to the QA Operations Team Leader within the Quality and Regulatory Affairs organization, located in Grens, Switzerland, and is an on-site position.