Be part of something altogether life-changing! 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. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Quality Engineer for Cytiva assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. Assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data.
In this role, you will have the opportunity to: Support transfer from New Product Introduction to high volume manufacturing and develop quality control plans. Implement and maintain, as a team member, Standard Operating Procedures, Process flow charts, Process Control Plans, Process FMEA, and Validations. Manage Change Control, Non-conformance, Corrective Actions and Preventive Actions, and Complaint (internal and external) processes; ensure root cause analysis and effectively implement robust action plans. Follow-up and verification of CAPAs to ensure no recurrence. Facilitate the closures of these in a timely manner. Provide Manufacturing Quality Trend Charts/Analysis and suggest/implement continuous improvement practices, including appropriate kaizen events on relevant processes based on trends. Support shin Kaizen events and use Lean manufacturing principles, as and when required. Utilize Danaher Business System to drive continuous improvements. Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with Purchasing/Sourcing departments to select/maintain/drop suppliers list based on their performance. The essential requirements of the position include:
Bachelor's degree in an engineering field (e.g. Biomedical, Chemical, Pharma, Industrial, Mechanical, Systems, Quality, Reliability) or equivalent work experience. At least 3 years of experience on a manufacturing or relevant environment Understands and applies Lean Six Sigma tools for problem solving, risk assessment, and process control. e.g. Voice of Process, Design for Reliability and Sustainability, Problem Solving Proces (DEMAIC), Value Stream Mapping. Ability to travel 5-15% (domestic and international) Proficient with Microsoft Office Tools (including Outlook, Teams, Excel, and Word). It would be a plus if you also possess previous experience in: Knowledge of the following software/systems: Veeva, SAP, Magic (Enovia). Product line transfers and new product introduction Customer facing technical writing and conflict resolution. This job is also eligible for bonus/incentive pay.
We offer comprehensive package of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.
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At Danaher we bring together science, technology and operational capabilities to 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. Our global teams are pioneering what's next across Life Sciences, Diagnostics, Biotechnology and beyond. For more information, visit .
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