BD (Becton, Dickinson and Company) Quality Engineering Lab Technician II in Covington, Georgia
Job ID: 2018-12184
Career Level: experienced
Location: Covington,Georgia,United States
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.
Essential job Functions:
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.
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 BMD 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 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 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.
Basic knowledge of medical device regulation, industry or international standard.
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.
Education and/or Experience:
Technical degree or Associate degree in a science field is a plus
Prior laboratory experience desirable
American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) is a plus
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 instruments.
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