Devy Missner Email & Phone Number

Quality management system practitioner with experience in ISO 9000, HACCP, GMP. Coordinated certification project for previous companies to comply with international standards. Lead of small project related to SPC, active trainer of quality tools (Fishbone, checklist, pareto). Experienced being representative of quality management system in the past hence gap-analysis skill in-hand. Established comprehensive quality improvement program spreaded from 5S-program, internal audit, ISO14000 training, SPC practices incorporated with incentive program to create quality-mindset throughout organization. Experienced CAPA system such as 7D, 8D and alike. Created production part approval process, master batch records. Industrial Engineering and Management Bachelor of Science background. Learning expected practices from FDA regulation at the moment. Goals: To participate and play active role in practicing and establishing lean manufacturing, with total quality management throughout organizationSpecialties: Regulatory practitioner (including the latest update on 21 CFR Part 117), PPC, quality improvement project, quality analyst, international standard, FMEA, CAPA, trouble-shooting leadership, industrial and organizational psychology, time-study, training.

Listed skills include Quality System, Manufacturing, 5S, Quality Assurance, and 41 others.