Full Job Description
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
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.
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.
Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.
#LI-TC2
