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 Primary Engineer located in Covington, GA.
This position is responsible for working in the BD Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities. Quality results are expected to ensure the integrity of BD complaint investigations.
Represents the Corporation, Division and Quality Department in a professional manner.
Provides support to Project Teams and Quality Department.
Responsible for all products testing in the Complaint Laboratory.
Creates investigation files in the BARD Global complaint system (Trackwise).
Performs complaint investigations for all BMD and OEM manufactured products
Manages completion of assigned complaint investigation files and works with the manufacturing site, where necessary, to complete the investigation within a timely fashion.
Creates, reviews and approves Quality System Documents (CAPA, Audits, SPAs and R002s)
Creates, reviews and approves SOP Documents.
Sets up, safely operates, and maintains laboratory equipment and testing instruments.
Performs tests and experiments in accordance with the requirements of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP).
Develops and maintains a working knowledge of BMD policies and procedures and ISO and FDA requirements.
Maintains accurate data, analyzes and summarizes conclusions drawn from investigation and product analysis .
Performs tasks accurately and with great attention to detail.
Must be able to work in a biohazard environment and comply with safety policies and procedures outlined by Bard policies
Ensures compliance to Department and Division procedures.
Interfaces with manufacturing facilities, suppliers, and PLM groups.
May present data findings to peers, engineering and management staff.
Technical competence in testing and writing and responsible for timely notifications based on new information received to FA specialists to meet FDA reporting requirements.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements included in this job description 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 engineering work of a broad nature with little or no direction from Quality Management. Generally, receives guidance on novel or controversial problems.
Basic knowledge of medical device regulation, industry or international standard.
Broad knowledge of Medical Device complaint reporting requirements.
Good laboratory skills, along with a working knowledge of laboratory bench methods and associated equipment.
Understanding of laboratory instrumentation.
Good understanding of OSHA requirements, Quality Systems Regulations (QSR), Good Laboratory Practices (GLP), ISO, AAMI, and FDA Guidelines, as well as any other regulations/requirements as they pertain to the laboratory.
Broad knowledge of manufacturing processes.
Excellent communication skills (verbal, written, and presentation). Understands how to present information dependent upon the level of the audience.
Understands Fundamentals of Engineering Principles.
Ability to effectively manage time and manage priorities to meet deadlines.
Ability to handle multiple task assignments.
Ability to interpret Corporate, Division and Department Procedures.
Ability to work with minimal supervision.
Ability to work in a team.
Prior laboratory experience desirable
B.S. in Engineering, Engineering Technology, Science a minimum.
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
Experience with Access Databases, Excel (PIVOT Tables and Charts) and complaint handling software (Trackwise or Pilgram)
Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear. May occasionally lift objects up to 25 lbs. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This position works in a normal lab/office environment. The noise level in the work environment is quiet to moderate.
Work environment requires operating and maintaining laboratory test equipment and measurement instruments.
Career Level: experienced
Relocation Available?: yes
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
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.