Bard has joined BD, together advancing the world of health. BD Urology & Critical Care, formerly Bard Medical, is looking to fill the position of Quality Engineer I located in Covington, GA.
Summary of Position with General Responsibilities:
This position performs tasks to remediate technical files ensuring compliance to EU MDR and various quality-engineering functions. This includes working to support Design Control projects as well as other duties in support of the Quality System, Design Control System, Document Control, Manufacturing, and the R&D / Product Development departments.
Represents the Corporation, Division and Quality Department in a professional manner
Remediate technical files to ensure compliance to EU MDR. Ensures that principals of Design Control are applied to product documentation.
Creates and reviews Quality System Documents
Creates and reviews Product Documents
Creates and reviews Test Methods and addresses Test Method Validation
Creates/reviews Protocols, Process and Product Validations, Stability Protocols
Creates and reviews documents required for Design History File
Creates and reviews Risk Assessments such as FMEA, FMECA or FTA
Ensures compliance to Department and Division procedures
Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner
Interfaces with manufacturing facility or other Division Facilities as required
Supports root cause investigations and other steps of the CAPA process as required
Provides guidance to test technicians/quality inspectors as required
Travels as required by the above duties and responsibilities as required
To perform this job successful, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this section and below are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Ability to perform detailed engineering work under direction of a Quality Management. May require consultation and direction to complete the essential duties and responsibilities
Understands basic applied statistics
Ability to participate on teams and maintain positive work environment with those teams.
Good communication skills (verbal, written, and presentation)
Understands Basic Fundamentals of Engineering Principles
Ability to effectively manage time
Ability to handle multiple task assignments
Ability to translate quality requirements into product specifications
Ability to interpret Regulations, Corporate, Division and Department Procedures
Education and/or Experience:
BS in Engineering, Engineering Technology, Science a minimum
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred
Minimum 1 years of experience with FDA regulated industry
About BD / CR Bard
BD Urology and Critical Care is currently hiring a Quality Engineers, Risk Management, Post Market Programs, & Quality Engineer I(s). These positions are a growth opportunity based in Covington, GA. Formerly Bard Medical, we have joined Becton-Dickinson a global medical technology company that is advancing the world of health by improving medical discovery, diagnostics and the delivery of care.