Quality Engineer (Complaint Handling) - Duncan, SC

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 Team reporting to the Quality Team Manager located in Duncan, SC and will be an on-site position.

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.
• 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

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.

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