BD (Becton, Dickinson and Company) Quality Engineering Lab Technician II in Covington, Georgia
The Quality Engineering Lab Technician II is located at BD (Bard) in Covington, GA.
Responsible for working in the Bard Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities. quality results are expected to ensure the integrity of Bard complaint investigations.
Represents the Corporation, Division and Quality Department in a professional manner.
Provides support to Project Teams and Quality Department.
Responsible for all product testing in the Complaint Laboratory. Quality results are expected to ensure the integrity of complaint investigations.
Provides Quality Engineering technical support to assist in resolving quality issues, including but not limited to complaint review and investigation.
Performs complaint investigations for all Covington and OEM manufactured products
Creates investigation files in the BARD Global complaint system (Trackwise).
Coordinates assigned complaint investigation files and works with the manufacturing site to complete the investigation within a timely fashion.
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 assists in drawing conclusions.
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 outlines by Bard policies.
Ensures compliance to Department and Division procedures.
Interfaces with manufacturing facility, International Marketing or other Division Facilities.
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.
Comprehensive knowledge of quality systems and relationship to business.
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.
Ability to participate and provide quality leadership on improvement teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.
Broad knowledge of Medical Device complaint reporting requirements.
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.
Ability to handle multiple task assignments.
Ability to translate quality requirements into product specifications.
Ability to interpret Regulations, Corporate, Division and Department Procedures.
AS/Technical degree desired
Prior laboratory experience desirable
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) is a plus
Minimum 3-5 years of experience with FDA regulated industry, including co-op/internship experience.
Proficiency with using MS Excel (pivot tables, v-lookup, etc)
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 instructions.
Industry Standard/Category: QE Lab Technician/Quality Engineering
Career Level: experienced
Division Name: Bard Medical
External Company Name: C.R. Bard, Inc.
External Company URL: www.crbard.com
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.