C. R. Bard, Inc.

  • Quality Engineer I

    Posted Date 1 month ago(4/23/2018 10:46 AM)
    Industry / Category
    Quality Engineer I/Quality Assurance
    Job ID
    2018-11127
    Career Level
    entry level
    Division
    Bard Medical
    Relocation
    Yes
    Location
    US-CO-Louisville
  • Overview

    BD Urology and Critical Care a BD Company is seeking to fill the position of Quality  Engineer I in Louisville, CO.  Formerly Bard Medical we are in the business of advancing lives and the delivery of healthcare.

     

    Summary of Position with General Responsibilities

    The Quality Engineer I will assist quality systems management in maintaining compliant and efficient Quality Systems. The position will provide support to project management teams to assist in compliance requirements existing and new, and direct team facilitation for Quality Engineering and/or Quality System daily activities.  Additionally, the Quality Engineer II will become a subject-matter resource for Risk Management, Quality Systems, Auditing, Compliance, Supplier Management and Improvement.  The Quality Engineer II will be involved with risk management, failure analysis, performing internal and supplier audits to verify compliance with ISO and FDA/QSR Regulations, supporting external audits, corrective and preventive action, and personnel training.  

    Essential Job Functions

    • Assist management with Capital Equipment and Disposables from a compliance and quality systems perspective. Responsible for leading complaint reduction initiatives and providing project management support to quality engineers on new product development (NPD) or sustaining engineering (SE) projects.      
    • Develop and improve quality systems to facilitate business and quality objectives.
    • Ensure timely independent quality assessment of systems, reports, internal/external facilities and documents that meet the company standard for quality and format.
    • Ensure risk-based decision making is incorporated throughout the product lifecycle including, creating a Risk Management file for Quality Engineering and performing Design History File audits for projects.       Provide leadership in implementing and maintaining to the latest ISO 14971 risk management to medical devices.
    • Maintain and enhance compliance to ISO requirements and other international regulations by performing gap analysis, as required to ensure compliance to local, divisional and corporate procedures.
    • Creates reviews and approves Quality System Documents.
    • Responsible for assisting with creation of Quality Plan, Quality Objectives, quarterly Management Review, monthly Complaints meetings, Quality Agreements (internal sites with different quality systems, globally for service and repair, and other countries MoH) and other reports as requested by management.
    • Responsible for communicating with notified bodies, completing audit applications and requests for information, hosting both internal and external audits. Performs external supplier audits and/or assessments.
    • Interfaces and represents the design center with Division in a professional manner by actively participating on Supplier Management Committee (SMC), CAPA Board, Remedial Action Plan (RAP) Meetings & other audit action plans (AAP), as required.
    • Provide oversight and review of corrective and preventive action, familiarity with DMAIC and root cause investigation techniques.
    • Tracks and trends Quality Indicators (such as Preventative Maintenance (PM) and software upgrades) both domestically and globally. Prepares and analyses periodic Quality Reports.
    • Collect, analyze and take action on performance measurement indices, statistical capability/ reliability analysis, as required
    • Participate in review product requirements for traceability, risk remediation and testability, as required.
    • Enhance the Quality Management System in such areas as Design Review Process, Compliance to Standards, Change Management, Device History File (DHF) and Approved Suppliers

    Basic Qualifications

    • 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 has fundamental knowledge of validation principles.
    • Understanding of auditing principles and ability to be lead auditor and mentor auditors in training.
      • Broad knowledge of product development, manufacturing, regulatory and purchasing processes, a plus.
      • 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.
      • Ability to interface with regulatory bodies to present technical information.

    Additional Desirable Qualifications Skills and Knowledge

    • Quality System Regulations 21 CFR 820

    • ISO 13485:2016 Quality Management System

    • ISO 14971:2007 or latest Application of Risk Management to Medical Devices

    • Medical Device Single Audit Program (MDSAP)

    • Consolidation Medical Devices Regulations (CMDR) SOR 98-282 2017

    • Resolution RDC 16/2013

    • MHLW Ministerial Ordinance No. 169

    • Therapeutic Goods (Medical Devices) Regulations TG(MD)R 2002

    • Medical Device Directive (MDD) 93/42/EEC Annex 2

    LANGUAGE SKILLS

    Able to communicate to multiple levels within the organization.

    Able to communicate within cross functional teams.

     

    MATHEMATICAL SKILLS 

    Well versed in analytical reasoning skills based on data

    Basic applied Statistics, statistical sample size calculation and plans, knowledge of basic reliability concepts, confidence intervals, ANOVA, t-tests, normality tests, attribute vs. variable data analysis, regression analysis and DOE.

    Education and/or Experience

    • Bachelor of Science Degree, with a minimum of (7) seven years of engineering experience is required. Master’s degree preferred.
    • At least 5 years’ experience in a FDA Regulated Industry, including three years on product development team, preferred.
    • American Society of Quality (ASQ) Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA) desired
    • Six Sigma Green Belt or Black Belt training desired.
    • Project Management training desired.
    • Regulatory Affairs Professionals Society (RAPS) participation desired.
    • A candidate with diverse experience with design controls, new product development, sustaining engineering, operations, supplier quality, regulatory and/or purchasing desired.
    • Proficient with Excel and use of Pivot Tables

     

    Physical Demands

    Employee may be required to sit, bend, stoop, use keyboard, see, talk and hear.  May occasionally lift objects up to 50 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.  #LI-CW1

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