C. R. Bard, Inc.

Sr. Quality Engineer

1 month ago
Industry / Category
Sr. Quality Engineer/Quality
Job ID
2017-10718
Career Level
experienced
Division
Bard Medical
Relocation
Yes
US-PA-Warrendale

Overview

The Sr. Quality Engineer position is located in Warrendale, PA at the Manufacturing Facility for C. R. Bard Medical Division. 

Summary of Position with General Responsibilities

The purpose of this position is to assist Quality Assurance Management in providing technical leadership in resolving and preventing quality issues.   This includes the responsibility to provide leadership on teams and maintain a positive work environment with those teams, understand team functions, leadership techniques and project management methodologies. 

Essential Job Functions

  • Represents the Corporation, Division and Quality Department in a professional manner
  • Performs Complaints review and complaint Investigations for disposable or capital equipment medical devices and the relationship between the two
  • Interacts with BMD Sales Force, customers (end users and hospitals), Field Assurance and manufacturing facilities on complaint related issues
  • Creates and reviews investigation files in the BARD Global Complaints System (Trackwise)
  • Provide Quality Engineering Support to assist resolving quality issues
  • Perform failure investigations and implement comprehensive corrective and preventive action plans using methodologies as Six Sigma/Lean Six Sigma
  • Develop Quality Indicators to enhance and monitor quality of products
  • Participates on Project Team as Quality Representative.  Ensures the principals of Design Control are applied to Product and Process Changes and New Product Development
  • Provides Quality Assurance leadership for Project Teams or Quality Department.
  • Creates, reviews and approves Quality System Documents (CAPA, Audits)
  • Creates, reviews and approves Product Documents, such as Design History Files
  • Creates, reviews, and approves Protocols, Process and Product Validations, Stability Protocols, Software Validation documents
  • Creates, reviews and approves Risk Assessments such as FMEA, FMECA or FTA.
  • Provides supervision to technicians and engineers
  • Analyzes process and product non-conformances and implement comprehensive corrective and preventive action plans.
  • Performs Internal or Supplier Quality System Audits.
  • Ensures compliance to Department and Division procedures.
  • 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.
  • Performs Complaint review and investigation as required.
  • Tracks and trends Quality Indicators.
  • Interfaces with manufacturing facility or other Division Facilities.

 

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.
  • Extensive knowledge of medical device regulation, industry or international standard, including management responsibility. 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.
  • Experience in writing process, software, and equipment protocols/validations and has fundamental knowledge of validation principles.
  • Problem solving skills
  • Understands applied statistics, statistical sampling plans, and statistical process control and advanced statistical methodologies such as DOE and Taguchi.
  • Ability to participate and provide leadership on teams and maintain positive work environment with those teams. Understands team functions, leadership techniques and project management methodologies.
  • 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.

Education and/or Experience

  • B.S. in Engineering, Engineering Technology, Science a minimum. 
  • American Society of Quality (ASQ) certification (CQE, CQA, CQM, Six Sigma Green Belt or Black Belt, etc.)
  • Minimum 4 years of experience with FDA regulated industry including three years on product development programs.

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 office environment.  The noise level in the work environment is quiet to moderate. 

Frequent travel is required.  When traveling to clinical sites or hospitals, the work environment will be specific to the area under evaluation.

 

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