- Roswell, GA, USA
- Full Time
Medical , Dental, Vision, FSA, HSA, Short Term Disability, Long Term Disability, Life Insurance, Telehealth, 401k and more.
KEY DUTIES AND RESPONSIBILITIES
- Supports root cause analysis efforts for CAPA, Nonconforming Product, Deviations, and Investigations.
- Initiates and completes investigations to address in process errors. non-conforming materials or products.
- Develops process improvements and implements manufacturing process changes.
- Recommends course of action through generation and analysis of data to remediated and reduce process variation.
- Develops and implements methods for sampling, inspection, testing, and evaluation of products and processes.
- Develops and implements statistical methods and design of experiments to support process development, process control, and process improvement.
- Develop and write specifications, work instructions, part specifications, and internal test methods.
- Support change control and material review boards
- Publish monthly KPIs for manufacturing metrics
Bachelor's degree in Engineering with at least Five (5) years of related experience. If Quality Engineering background, experience in an FDA, ISO and/or AATB regulated facility is a plus.
Experience with manufacturing process in a regulated environment that requires documented investigations. remediation and closure of process deviations.
Knowledge and understanding of regulatory requirements associated with the installation and validation of equipment and processes according to FDA, AATB and other applicable state and federal regulations. Thorough understanding of key quality engineering tools including: FMEA, DFMEA, PFMEA, IQ, OQ, PQ, TMV, control plans, process verification, process validation, Cpk, SPC, DOE, Ppk, process data analysis, DMAIC, Lean, ANSI/ASQ, AQL Experience with electron beam sterilization processes, validation, and maintenance. Understanding of ISO11137 and ISO14644.