Quality Engineer (Complaint Handling) - Duncan, SC

Danaher•Duncan, OK

8h•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

Lean Six Sigma
Knowledge of the following software/systems: Veeva, SAP, Magic (Enovia).
Technical writing

Responsibilities

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.