Senior Quality Engineer
On-siteConcord, North Carolina, United States
Job Summary
Conduct statistical analysis of new and existing processes using design of experiments to identify root causes of product defects and process waste. Lead investigations to recommend corrective actions, support CAPA investigations, and develop action plans. Provide guidance to the Engineering Department for Plant Validation Program protocols, including prospective, retrospective, and revalidation efforts. Acquire data from critical processes for trend analysis and maintain statistical process control by reporting daily quality states at management meetings. Coordinate the overall quality effort within the plant, including weekly Gemba audits for QSR and FDA compliance, and conduct vendor quality evaluations. Operate within Safety and QSR guidelines of BD-Sumter.
Required Qualifications
- BA/BS Degree (Major: Engineering, Sciences, Mathematics, or equivalent)
- Minimum of BA/BS Degree AND 3 years' work experience in Quality Assurance/Manufacturing
- MSc. Degree AND 2 years' work experience
- Proven understanding of statistical/investigative tools such as control limits, SPC, significance studies, P charts, probability studies, 8D, 5-Why
- Effective written and verbal skills with the ability to accept responsibility and perform responsibilities with minimal direction
- Working knowledge of Validations, IQ, OQ, PQ, and DOEs
Desired Qualifications
- Proven understanding of ISO13485:2016
- Six Sigma training
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.