C. R. Bard, Inc.

Quality Engineer II -Data Scientist

1 week ago
Industry / Category
Quality Systems Engineer
Job ID
2016-9326
Career Level
experienced
Division
Bard Medical
Relocation
Yes
US-GA-Covington

Overview

The Quality Systems Engineer II is located in Covington, GA at Bard Medical Division.

Summary of Position with General Responsibilities

The purpose of this position is to assist Quality Systems Management in maintaining a Quality Systems information systems. This includes assisting other Quality Systems personnel with the proper tools and guidance to be successful in performing their work. Additionally, the Quality Systems Engineer functions as a subject-matter resource for Quality Systems and Quality Assurance Management.

Essential Job Functions

  • Represents the Corporation, Division and Quality Department in a professional manner.
  • Creates, reviews, and distributes Quality System Indicators / Metrics. Emphasis on coordinating data management systems and reporting systems (automated, semi-automated, and manual utilizing corporate and division databases).
  • Tracks and trends Quality Indicators / Metrics; supports periodic review meetings.
  • Interfaces with manufacturing facility or other Division Facilities.
  • Ensures compliance to Department and Division procedures.
  • Provides work direction as required.
  • Performs Complaint review and investigation as required.
  • Performs Internal or Supplier Quality System Audits.
  • Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.
  • Participates on Project Team as Quality Representative. Ensures that principals of Design Control are applied to Product and Process
  • Changes and New Product Development.
  • Provides support for Project Teams or Quality Department as required such as generating RFS, ECR, PQR, etc. as required.
  • Creates and reviews Product Documents
  • Creates and reviews Test Methods
  • Creates/reviews Protocols, Process and Product Validations, Stability Protocols
  • Creates and reviews documents required for Design History File.
  • Creates and reviews Risk Assessments such as FMEA, FMECA or FTA.
  • Participates and has membership in trade and/or professional organizations to ensure that state-of-the-art industry standards are communicated into the division in an efficient, timely, and accurate manner.
  • Travels as required by the above duties and responsibilities.

Basic Qualifications

  • Ability to perform detailed engineering work under direction of a Senior Engineer or Quality Management. May require consultation and direction to complete the essential duties and responsibilities.
  • Strong Data Management and Report Presentation Skills.
  • Advanced Microsoft Access and Microsoft Excel skills a must.
  • Ability to create and qualify pivot tables, pivot charts, macros, queries, forms, reports, etc. across applications.
  • Understands basic applied statistics.
  • Has fundamental knowledge of validation principles.
  • Comprehensive understanding of auditing principles; lead auditor experience a plus.
  • Ability to participate on teams and maintain positive work environment with those teams.
  • Good communication skills (verbal, written, and presentation)
  • Understands Basic 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.

Education and/or Experience

  • A four-year degree in Engineering, Engineering Technology, Science or equivalent.
  • 5+ years experience with FDA regulated industry a plus.
  • American Society of Quality (ASQ) certification (CSQE, CQE, CQA, etc.) a plus

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

Normal office environment - noise level is quiet to moderate - frequent travel is required - when traveling to clinical sites or hospitals, work environment will be specific to the area under evaluation.

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