Be part of something altogether life-changing! Working at Cytiva in the Life Sciences industry 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 (Complaint Handling) for Cytiva is responsible for driving quality adherence, process change and risk assessment in a high volume manufacturing facility.
This position is part of the Quality Assurance department located in Duncan, SC and will be an on-site position. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery.
What you'll do: Manage product failure/non-conformance, CAPA and Complaint (internal and external) processes; complete root cause analysis and effectively implement robust action plan. 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. Roll out CDT&R, VOC, DRS, PSP, FMEA- utilize DBS to drive continuous improvements. Work closely with cross-functional teams/areas: engineering, quality, manufacturing, customer service. Who you are: Bachelor's degree in an engineering field (e.g. Biomedical, Chemical, Pharma, Industrial, Mechanical, Systems, Quality, Reliability) with 3+ years of experience in a manufacturing or highly regulated environment OR 7+ years of work experience in a manufacturing or highly regulated environment. Proficiency with data analysis and applying tools in problem solving, risk assessment, process validation and change control. Proven agility working with cross-functional teams. Demonstrated experience in customer facing interactions and conflict resolution. Proficient with Microsoft Office: Outlook, Teams, Excel, and Word. It would be a plus if you also possess previous experience in: Lean Six Sigma Knowledge of the following software/systems: Veeva, SAP, Magic (Enovia). Technical writing
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