C. R. Bard, Inc.

  • Quality Engineering Manager

    Posted Date 3 weeks ago(9/21/2018 8:48 AM)
    Job ID
    2018-12290
    Career Level
    management
    Division
    BD-UCC
    Relocation
    yes
    Location
    US-GA-Covington
  • Overview

    This position provides Quality Engineering and Quality Assurance technical expertise and functional leadership in support of the Acute Care Franchise for all aspects of the Product Life Cycle.

    Essential Job Functions

    • Represent the Corporation, Division and Quality Department in a professional manner.
    • Manage and ensure proper implementation of all 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, and design control regulations, etc.
    • Participate on project teams as the Quality Representative. Ensure that principals of Design Control are applied to Product and Process Changes and New Product Development.
    • Provide technical support for Franchise Project Teams and the Quality Department.
    • Create, review and approve Quality System Documents.
    • Create, review and approve Product Documents for products purchased, manufactured and/or distributed by BD UCC.
    • 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 (CAPA).
    • Lead efforts to identify, investigate, and create plans to respond to potential product issues involving distributed porduct.
    • Perform Internal and Supplier Quality 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.
    • Provide technical support for complaint and adverse event review and investigation.
    • Develop Quality indicators for new product launches and assure complaint metrics are monitored post launch. Communicate 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 an Independent QA Reviewer 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.
    • Lead Quality Engineers on the team to execute their duties including:
    • 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 design input requirements into design output documents.
    • Lead in Development of Risk Management Documentations.
    • Review and approve design verification and validation protocols and reports to demonstrate that the design output fulfills the design input requirements.
    • Review and approve design verification and validation reports.
    • Support supplier validations.
    • Develop and approve test plan for demonstrating conformance to specifications and establishing controls.
    • Prepare and execute Reliability protocols and report.
    • Review and approve IQ, OQ, and PQ protocols and final reports.
    • 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.
    • Technical writing skills.
    • Management skills.
    • Computer 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.
    • Experience in writing protocols/validations and fundamental knowledge of validation principles.
    • Understanding of applied statistics, statistical sampling plans, and statistical process control.
    • 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. Understanding of team functions, leadership techniques and project management methodologies. 
    • Broad knowledge of manufacturing processes.
    • Ability to effectively manage time.
    • Ability to handle multiple task assignments.

    Additional Desirable Qualifications Skills and Knowledge

    MATHEMATICAL SKILLS:

     

    • College level mathematical skills.
    • Basic applied Statistics, statistical sampling plans, statistical process control, DOE, Taguchi Methodology.
    • Reliability tools
    • Able to take theoretical mathematics and apply to business problems.

     

    REASONING ABILITY:

     

    Complexity:  Highly variable operations performed daily, from complex regulatory and engineering decisions to routine administrative functions.  This position involves reviewing and making decisions involving Personnel, Statistics, Engineering, document Control, Policy, Procedure, Specifications, Quality Acceptance, Product Development, and Regulatory Compliance issues.

     

    Judgement:  The position involves making decision involving all areas mentioned above.  In some instances, there are written policies or procedures that have to be interpreted.  In some instances, only judgment based on past experience can be used. 

    Education and/or Experience

    • Four (4) year Engineering or Science degree.
    • Eight (8) + years experience in a decision-making quality engineering position or equivalent quality related experience with at least 2 years in FDA Regulated Industry.
    • American Society of Quality (ASQ) Certified Quality Engineer or Certified Quality Manager desired
    • Six Sigma Black Belt training desired

    Physical Demands

    The physical demands as required to perform the essential functions of this job are those of a basic office environment and ability to travel as needed.  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.
    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed