C. R. Bard, Inc.

  • Sr. Quality Engineer

    Posted Date 2 months ago(9/28/2018 2:59 PM)
    Industry / Category
    Medical Device / Quality Engineering
    Job ID
    Career Level
    BDI Surgery - Woburn
  • Overview

    BD Interventional’s Surgery worldwide business unit, located in Rhode Island, is a leading developer, manufacturer, and marketer of innovative, life-enhancing medical technologies. For the past 40 years, we have stood out as the market leader in providing solutions in soft tissue reconstruction including products for hernia repair, specialized surgical procedures, fixation and biologic implants. In addition to this extensive suite of products, our BioSurgery business is delivering a growing line of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic, cardiovascular and other surgical specialties. 

    Our company has a strong tradition of developing our employees to learn, grow and excel. We are continually building our team with qualified, team oriented individuals to enhance the success of our company. 

    BDI Surgery's Woburn, Massachusetts manufacturing facility manufactures hemostasis products, hernia and abdominal wall repair products. The facility also manufactures biological odor eliminators and creams/gels for BDI Interventional's Urology & Critical Care business unit, which is used primarily in hospitals and nursing homes. 

    Summary of Position with General Responsibilities

    This position will serve as the Quality Engineering lead for the Woburn Manufacturing facility.  The primary responsibilities center on resolving manufacturing issues by implementing effective solutions, revising facility documentation for accuracy and compliance, validating equipment/processes/product as needed, and identifying/implementing continuous improvement projects.

    Essential Job Functions

    • Oversee the Material Review Board (MRB), which includes providing leadership and coordination of activities for the investigation and disposition of non-conforming product and/or components
    • Identify and resolve issues in the manufacturing of Class III PMA medical device products, by designing and conducting Quality Engineering investigations, and working directly with manufacturing engineering, operators, and other plant personnel
    • Provide technical guidance to the staff and mentorship to quality and manufacturing engineers
    • Document risk-based rationales as needed throughout the Quality Management System
    • Write and execute validations (IQ/OQ/PQ) and qualification studies as needed for new/existing equipment (inspection & process), software, components, etc.
    • Manage CAPAs and Audit Action Plans to completion using risk analysis, project management, and proper effectiveness verification methods.
    • Revise procedures as needed based on nonconforming material investigations, CAPA, complaints, continuous improvement projects (CIP), and compliance to local, division, and corporate procedures, in addition to local and international quality regulations.
    • Represent the Quality function on committees, teams, task forces as assigned
    • Support the goals of the Quality Control Dept. and the Woburn Manufacturing facility
    • Special projects as assigned

    Basic Qualifications

    • Bachelor’s Degree in technical area
    • Minimum 5 years within medical device industry, preferably in Class II/III manufacturing environment
    • High level of competence in Quality Technology including statistical techniques, control charts, sampling plans, process capability, process/equipment validation, Gage R&R, design of experiments, correlation and regression, analysis of variance, probability, etc.
    • ASQ Certified Quality Engineer and/or Six Sigma Black Belt strongly preferred
    • Strong statistical software and MS Project skills
    • Strong oral and written communication skills
    • Ability to motivate people and mentor engineers
    • Understanding of ISO 13485, MDD/MDR, GMP, QSR, and other applicable regulations, and the ability to interpret these as they apply to company issues
    • Strong project planning skills focused on meeting customer needs
    • Proven leadership skills in a fast paced environment

    Additional Desirable Qualifications Skills and Knowledge

    • Master’s Degree preferred

    Education and/or Experience

    BD Interventional and Becton Dickinson are Affirmative Action/Equal Opportunity Employers, M/F/D/V. VEVRAA Federal Contractor.



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