BD (Becton, Dickinson and Company) Quality Engineer I in Covington, Georgia
Job ID: 2018-12430
Career Level: experienced
Location: Covington,Georgia,United States
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 various quality-engineering functions and associated support tasks in developing knowledge and experience in the areas of Quality Assurance/Document Control/Design Control. 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.
Essential job Functions:
Represents the Corporation, Division and Quality Department in a professional manner
Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process Changes and New Product Development
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
Provides guidance to test technicians/quality inspectors as required
Creates and reviews documents required for Design History File
Creates and reviews Risk Assessments such as FMEA, FMECA or FTA
Performs Internal or Supplier Quality System Audits
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
Supports root cause investigations and other steps of the CAPA process
Travels as required by the above duties and responsibilities
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 Senior Engineer or 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
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects of 10 to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Office and manufacturing environments
May include visits to clinical sites or hospitals
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status