C. R. Bard, Inc.

Quality Systems Manager

2 weeks ago
Industry / Category
Quality Manager/Quality
Job ID
2017-10597
Career Level
management
Division
Bard Medical
Relocation
Yes
US-GA-Covington

Overview

Establishes, directs and ensures that all document control, training, compliance, CAPA and management reporting activities are in compliance with the FDA Quality System Regulation, other FDA Regulations, ISO and other international regulations that apply to the products manufactured by Bard Medical. Subject matter expert for MasterControl, Change Control, Training, Internal Audits, Notified Body assessments, FDA audits, and quality systems compliance.

 

Summary of Position with General Responsibilities

  • Maintains the integrity of the Documentation Systems and associated documentation.
  • Maintains the Training System, including position requirements, and evidence of training completion for BMD employees.
  • Provides training on the Documentation Systems and associated policies and procedures
  • Manages the CAPA system and develops the CAPA Board meeting schedule.
  • Facilitates CAPA closures to meet due dates.
  • Manages the Quality Systems staff which includes Document Control and Training Compliance, CAPA Coordinator, Recall Coordinator, Post Market Surveillance, and Engineering team to ensure proper implementation of their duties and responsibilities.
  • May serve as a QA representative in developing and maintaining Division Policies and Procedures.
  • Ensures the selection, orientation, development, and retention of a sufficient number of qualified staff to carry out the responsibilities of the department.
  • Maintains metrics for reporting to senior management for all Quality Systems.
  • Responsible for the execution of Field Actions and Post Market activities.

Basic Qualifications

  • Strong listening, assessment, questioning, analytical and problem-solving skill
  • Knowledge/understanding of FDA regulations, ISO standards, and other industry standards for Medical Devices
  • Interpretation of regulations (QSR, ISO requirements, JPAL, etc.) into standards/procedures is required
  • Good knowledge of Statistical techniques, investigation techniques (5 Why’s, Ishikawa, etc), Quality Assurance principles, team functions, leadership techniques and project management methodologies
  • Understanding and practical experience in Design Control requirements, Risk Assessment as applied to Medical Devices (FMEA, FTA, Hazard Analysis, etc.)
  • Strong interpersonal skills required in areas of verbal/written communications, customer focus, professionalism, coaching, and team building.
  • Well versed in statistics, analytical reasoning skills based on data

Additional Desirable Qualifications Skills and Knowledge

 

Education and/or Experience

  • BS degree required in Engineering, Science, or Technical field required.
  • 7-10 years experience with FDA regulated industry
  • Minimum five+ years supervisory experience.
  • Proficient in Microsoft Office
  • ASQ, CQE, and CQA Certifications preferred

Physical Demands

Ability to travel as required for the position and lift up to 25 pounds

 

Work Environment

This position works in a normal office environment. The noise level in the work environment is quiet to moderate.  This position also has exposure to laboratory environment and manufacturing environments with associated conditions.

 

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