Operational Quality Assurance Engineer (f/m/d)

Cytiva; Grens; Presencial; CHF 90 000 - 120 000; Tempo integral

Resumo da oferta

Cytiva, a Danaher operating company, is seeking an Operational Quality Assurance Engineer to help ensure manufacturing and support processes meet QMS, regulatory, and customer requirements in Grens, Switzerland. You will drive product quality, support investigations, manage quality records, and collaborate with cross-functional teams to release compliant products.

You will lead investigations, deviations, change controls, and quality improvement initiatives, monitor quality KPIs, and apply DBS

Qualificações

• 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 within regulated manufacturing.
• Working knowledge of ISO 9001 and GMP requirements in regulated industries.

Responsabilidades

• Provide Quality Assurance support to Operations, Engineering, Supply Chain, QC, Logistics, and Supplier Quality functions to ensure compliance with customer, regulatory, and QMS requirements.
• Lead and support investigations, deviations, change controls, and quality improvement initiatives to drive corrective actions and process enhancements.
• Serve as SME for product release activities and ensure products are released in accordance with applicable quality requirements and business needs.
• Support validation and qualification activities and provide quality oversight for process and product changes.
• Monitor and analyze Quality KPIs, communicate performance trends, and support continuous improvement initiatives using DBS tools and methodologies.
• Establish cross-functional partnerships to promote quality culture, compliance, and operational excellence.

Conhecimentos

Quality Assurance

Quality Engineering

Quality Systems

English proficiency

French proficiency

Formação académica

Bachelor's degree in Science/Engineering/Life Sciences

Ferramentas

Veeva eQMS

TrackWise eQMS

MasterControl eQMS

Descrição da oferta de emprego

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Cytiva, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. Take your next step to an altogether life-changing career. Learn about the Danaher Business System which makes everything possible.

The Operational Quality Assurance Engineer is responsible for ensuring that manufacturing, engineering, and support processes comply with applicable Quality Management System (QMS), regulatory, and customer requirements. The role drives product quality, compliance, and continuous improvement by providing quality oversight, supporting investigations, managing quality records, and partnering with cross-functional teams to ensure the timely release of compliant products and implementation of sustainable quality improvements. This position reports to the QA Operations Team Leader and is part of the Quality and Regulatory Affairs organization located in Grens, Switzerland and will be an on-site role.

What You Will Do

• Provide Quality Assurance support to Operations, Engineering, Supply Chain, QC, Logistics, and Supplier Quality functions to ensure compliance with customer, regulatory, and QMS requirements.
• Lead and support investigations, deviations, change controls, and quality improvement initiatives to drive sustainable corrective actions and process enhancements.
• Serve as Subject Matter Expert (SME) for product release activities and ensure products are released in accordance with applicable quality requirements and business needs.
• Support validation and qualification activities and provide quality oversight for process and product changes.
• Monitor and analyze Quality KPIs, communicate performance trends, and support continuous improvement initiatives using DBS tools and methodologies.
• Establish effective cross-functional partnerships to promote quality culture, compliance, and operational excellence.

Who You Are

• 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 within Medical Device, Biopharmaceutical, Biotechnology, or other regulated manufacturing environments.
• Working knowledge of ISO 9001 and/or GMP requirements applicable to regulated industries.
• Experience managing quality records such as deviations, CAPA, change controls, investigations, or validation/qualification activities within an electronic Quality Management System.
• Professional proficiency in English and French.

Travel, Motor Vehicle Record & Physical/Environment Requirements

• Ability to work in manufacturing, laboratory, warehouse, and office environments.
• Ability to wear required personal protective equipment (PPE) and access controlled production areas when needed.

It would be a plus if you also possess previous experience in:

• Experience in Medical Device and/or Biopharmaceutical manufacturing environments.
• Experience with electronic Quality Management Systems (eQMS) such as Veeva, TrackWise, MasterControl, or equivalent.
• Knowledge of Danaher Business System (DBS) or Lean Continuous Improvement methodologies.

Cytiva, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it’s a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.