C. R. Bard, Inc.

Quality Engineer II, Design

Posted Date 4 weeks ago(1/26/2018 1:20 PM)
Industry / Category
Quality Engineer/Quality Assurance
Job ID
2017-10940
Career Level
experienced
Division
Bard Medical Division
Relocation
Yes
Location
US-CO-Louisville

Overview

These Quality Engineer II, Design  position is located in Louisville, Colorado at a Design Center for C. R. Bard Medical Division.

Summary of Position with General Responsibilities

This position provides Quality Engineering and Quality Assurance technical expertise and functional support for new product development and sustaining product line support.

Essential Job Functions

  • Represent the Corporation, Division and Quality Department in a professional manne
  • Manage and ensure proper implementation of the Quality Engineering duties and responsibilities. Hire, train, develop, review, and manage exempt and/or non-exempt employees as assigned.
  • Provide Quality Engineering leadership for New Product Development (NPD), Sustaining Engineering (SE) and transfer to manufacturing.
  • Provide Quality Engineering technical support to assist in resolving quality issues including but not limited to complaint review and investigation.
  • Prepare and implement divisional policies relating to quality, project management, product/process development, design control regulations, etc.
  • Participate on project teams as Quality Representative. Ensure that principals of Design Control are applied to Product and Process Changes and New Product Development.
  • Provide technical support for NPD and SE Project Teams or Quality Department.
  • Create, review and approve Quality System Documents.
  • Create, review and approve Product Documents for products purchased, manufactured and/or distributed by BARD.
  • Create, review and approve Protocols, Process and Product Validations, Stability Protocols, etc. to support the Design History File (DHF).
  • Analyze process and product non-conformances and implement comprehensive corrective and preventive action plans.
  • Perform Internal or Supplier Quality System Audits.
  • Ensure compliance to Corporate, Division and Department procedures.
  • Participate and have 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.
  • Technical support for complaint review and investigation.
  • Develop Quality indicators for new product launches and assure complaint metrics are monitored post launch. Responsible for communicating complaint metrics back to the product development teams as part of awareness and continuous improvement.
  • Interface with manufacturing facilities or other Division Facilities as required.
  • Serve as Independent QA Reviewer and Chairperson for Design Reviews, Design History File Audits (DHFA) and data integrity audits.
  • Participate in worldwide business travel as required by the above duties and responsibilities.
  • QE duties include:
  • Lead in identification of device specific regulatory and performance standards that should be used in the formulation of the design input requirements.
  • Review and approve design input requirements.
  • Review and approve the translation of Input requirements into design output documents.
  • Lead in Development of Risk Management Documentations to include DFMEA.
  • Review and approve design verification and validation protocols and reports to demonstrate that the design output fulfills the design input requirements.
  • Review and approve all design verification and validation reports.
  • Support supplier validations.
  • Develop and approve test plan for demonstrating conformance to specifications and establishing controls.
  • Review and approve IQ, OQ, and PQ protocols and final reports.
  • Review the DMR.
  • Review and approve Test Methods.
  • Lead in post launch quality review.
  • Manage the Master Validation Plan (MVP) for projects.

Basic Qualifications

  • Strong Verbal and written communication skills and presentation skills.
  • Management, Computer and Technical Writing Skills
  • Knowledge and understanding of Document Control practices.
  • 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.
  • Has experience in writing protocols/validations and has fundamental knowledge of validation principles.
  • Understands applied statistics, statistical sampling plans, and statistical process contro.
  • Ability to serve in leadership roles on projects or assignments.
  • Comprehensive understanding of auditing principles and ability to perform as a lead auditor.
  • 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.

 

Education and/or Experience

  • Four (4) years Science or Engineering Degree
  • Five (5) years experience in decision-making quality engineering positon or equivalent quality related experience with at least two (2) years in a FDA Regulated Industry
  • ASQ-Certified Quality Engineer or Certified Quality Manager
  • Six Sigma Black Belt training desired

Physical Demands

The physical demands as required to perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

Work Environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Office environment
  • Manufacturing environments
  • May include visits to clinical sites or hospitals.
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