BD Urology and Critical Care a BD Company is seeking to fill the position of Quality Engineer I in Louisville, CO. Formerly Bard Medical we are in the business of advancing lives and the delivery of healthcare.
The Quality Engineer I will assist quality systems management in maintaining compliant and efficient Quality Systems. The position will provide support to project management teams to assist in compliance requirements existing and new, and direct team facilitation for Quality Engineering and/or Quality System daily activities. Additionally, the Quality Engineer II will become a subject-matter resource for Risk Management, Quality Systems, Auditing, Compliance, Supplier Management and Improvement. The Quality Engineer II will be involved with risk management, failure analysis, performing internal and supplier audits to verify compliance with ISO and FDA/QSR Regulations, supporting external audits, corrective and preventive action, and personnel training.
Quality System Regulations 21 CFR 820
ISO 13485:2016 Quality Management System
ISO 14971:2007 or latest Application of Risk Management to Medical Devices
Medical Device Single Audit Program (MDSAP)
Consolidation Medical Devices Regulations (CMDR) SOR 98-282 2017
Resolution RDC 16/2013
MHLW Ministerial Ordinance No. 169
Therapeutic Goods (Medical Devices) Regulations TG(MD)R 2002
Medical Device Directive (MDD) 93/42/EEC Annex 2
Able to communicate to multiple levels within the organization.
Able to communicate within cross functional teams.
Well versed in analytical reasoning skills based on data
Basic applied Statistics, statistical sample size calculation and plans, knowledge of basic reliability concepts, confidence intervals, ANOVA, t-tests, normality tests, attribute vs. variable data analysis, regression analysis and DOE.
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 50 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position works in a normal office environment. The noise level in the work environment is quiet to moderate. #LI-CW1