C. R. Bard, Inc.

Quality Engineering Lab Supervisor

2 months ago
Industry / Category
QE Lab Supervisor/Quality Engineering
Job ID
2017-9909
Career Level
experienced
Division
Bard Medical
Relocation
No
US-GA-Covington

Overview

The Quality Engineering Lab Supervisor position is located at Bard Medical Division in Covington, GA. 

Summary of Position with General Responsibilities

This position is responsible for working and supervising in the Bard Complaint Laboratory to perform product testing as well as planning, organizing, and tracking work activities for the Quality Engineering Lab Technicians. Quality results are expected to ensure the integrity of Bard complaint investigations.

Essential Job Functions

  • Represents the Corporation, Division and Quality Department in a professional manner.
  • Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
  • 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 and approves complaint investigations for all BMD and OEM manufactured products.
  • Creates investigation files in the BARD Global complaint system (Trackwise).
  • Supervises 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 field assurance, 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.

Basic Qualifications

  • 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.
  • At a minimum, intermediate level of knowledge of medical device regulation, industry or international standard.
  • Ability to understand Division and Plant Quality Systems and be able to implement systemic changes to enhance product quality and improve business efficiency.
  • Ability to interface with regulatory bodies to present technical information.
  • 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.
  • 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 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.

Additional Desirable Qualifications Skills and Knowledge

This position requires good judgement. All products and process development are to be carried out according to the applicable laws and regulations. When in doubt, the incumbent should source out the appropriate information via internal and external resources.

  • Ability to read, analyze, and interpret general technical procedures, or governmental regulations.
  • Ability to write reports, business correspondence, and procedures.
  • Ability to effectively present information and respond to questions from groups of managers, customers, and the general public.

 

Education and/or Experience

  • B.S. in Engineering, Engineering Technology, Science a minimum.
  • Prior laboratory experience desirable
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, etc.) preferred.
  • Minimum 5 years of experience with regulated industry and 3+ supervisory/management experience.
  • Proficiency with using MS Excel (pivot tables, v-lookup, etc.)

Physical Demands

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.

Work Environment

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.

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