BD (Becton, Dickinson and Company) Quality Engineer II in Covington, Georgia
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 II located in Covington, GA.
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.
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.
Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required.
Creates and reviews Quality System Documents
Creates and reviews Product Documents
Creates and reviews Test Methods
Creates/reviews Protocols, Process and Product Validations, Stability Protocols
Provides work direction 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.
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.
Knowledge of manufacturing processes
Comprehensive knowledge of quality systems and relationship to business.
Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
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.
B.S. in Engineering, Engineering Technology, Science a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.)
Minimum 5 years of experience with FDA regulated industry including 3+ years on product development programs.
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.
Career Level: experienced
Relocation Available?: Yes
Street: 8195 Industrial Blvd.
C. R. Bard, Inc. (NYSE: BCR) is a leading multinational developer, manufacturer and marketer of innovative, life-enhancing medical technologies in the fields of vascular, urology, oncology and surgical specialty products, employing over 13,000 people around the world. Founded in 1907, we pioneered many devices that are now the cornerstones of modern healthcare.
We expect the highest levels of quality, integrity, service, and innovation from our employees – on the job and in the communities in which we work and live. In return, we foster an environment where individuals are treated with fairness and respect, and feel valued, acknowledged and rewarded. Bard is a M/F, Disabled and Vet EEO/AA Employer.
Be Your Best at Bard – and ultimately, you can have an impact on the lives of people around the world.