resources. CMMI Maturity Level III and ISO 9001 – 2015 certified. Responsibilities: Helps manage the people side of the...
the ISO 9001 Standard as the basis for process development and optimization, procedure development, data collection... and reporting and Quality Systems training. Interfacing at senior and executive levels with regard to ISO 9000 process improvement...
and quality assurance requirements/blasting and painting procedures and established ISO-QA/QC program standards. Essential...
on experience with BIAN framework YES Translate APIs into ISO and BIAN YES Experience writing Requirements on APIs YES...
warehouse areas. Understands GMP, QSR, ISO and RMS Quality regulations and ensures operations are performed...
and ISO 13485. Experience with assessing quality and compliance impact on products for design and process changes...
; works with internal and external entities to do so as assigned by management. Responsible for ISO 9001 compliant filing...
procedures, work instructions, forms, and visual aids Experience working within an ISO 9001 QMS Experience with SAP At least 3...
development experience, and understanding of ISO 11607 packaging regulations. Designing in SolidWorks or any other system... background with medical device, packaging design development experience and understanding of ISO 11607 packaging regulations...
to processes. Good working knowledge and application of validation and statistical techniques. Understanding of ISO 13485, ISO...