Talent.com
Quality Manager
Quality ManagerITW Performance Polymers • Washington, NC, US
Quality Manager

Quality Manager

ITW Performance Polymers • Washington, NC, US
4 days ago
Job type
  • Full-time
Job description

Quality Assurance Manager

General Accountability :

This position reports to ITW Medical's Director, Quality Assurance & Regulatory and is responsible for Quality Assurance activities associated with the assigned location(s). The individual will be responsible for compliance / certifications, complaints / corrective actions, and for the financial aspect of the quality function specifically tied to ownership of scrap and non-value-add activity reduction. This individual will champion the use of the Divisional Quality Management System, drive a culture change away from quality control and towards quality assurance, leverage analytics and strategic decision making to drive continuous improvement, and lead a team of quality professionals and inspectors. This position will be responsible for the quality function at the assigned manufacturing location and for quality communication for key customers of those sites, and the division.

Duties and Responsibilities :

Customer-Facing Metrics (CFM) Drive actions to improve performance to CFMs

  • On-Time Delivery Ensure management of processes to help improve compliance to customer requested delivery dates and investigation of late deliveries to promote improvement.
  • Complaint Response Time Works with Quality Team, Peers, and other Team Members to ensure complaints are properly investigated, acted upon and responded to in a timely manner.
  • Complaint PPM Works with the Plant Management Team and other Team Members to reduce systematic contributors to defects and to ensure appropriate detection practices are implemented.
  • Scrap Drives improvement in and motivates team member engagement to identify effective solutions for scrap reduction.

Compliance / Certification

  • Maintain the FDA QSR / ISO 13485 compliant Quality Management System, including assignment of primary contacts and coordinating training support. Ensure 100% alignment with Divisional Standards.
  • Ensure Management Reviews are conducted to provide for systems review.
  • Manage Internal Audit Program.
  • New / Change Product / Process Validation

  • Oversee management of validation activities
  • Ensure appropriate protocols are written, identified actions are completed, and overall Validation reports are written.
  • Management of Implementation and Documentation of IQ, OQ, PQ
  • Ensure timely and conclusive validations, including validation reports.
  • Participate in Design Reviews, including Technical Reviews, Feasibility Discussion, and Failure Modes and Effects Analysis (FMEA).
  • Assist in documenting development work including supporting writing specifications for manufacturing or identifying and / or evaluating scientific test results.
  • Complaint / Corrective Action Management

  • Act as direct contact (where appropriate) or manage contact (through Quality Engineers) for customer quality-related issues; coordinate course of action for alleviating and resolving concerns and providing timely responses.
  • Identify corrective / preventive actions for continuous improvement (effectively implemented and closed in a timely manner) and quality improvement as needed for Production and Business Unit Goals.
  • Ensure completion of necessary paperwork such as Complaints, CAPA, Alerts, and other relevant documents.
  • Ensure Root Cause Analyses are conducted to establish reasons and solutions for Quality issues.
  • Continuous Improvement Activities

  • Maintain product supply with minimum Scrap and NVA activities.
  • Drive improvement by using data-based information to drive Scrap Reduction, elimination of NVA activities, and On-Time Delivery improvements
  • Use charts / graphs / data to lead / support scheduled meetings.
  • Review Batch Release and DHR compilation, with a view to automating and reducing time for completion
  • Offer input for areas of improvement in products, processes, and procedures.
  • Manage Department

  • Provides partnership with our First Team to champion employee engagement efforts.
  • Manages talent acquisition and develops new hire onboarding plans as needed.
  • Provides frequent performance feedback and completes annual reviews for the team.
  • Guides the Quality team to manage daily production activities with minimal direct supervision.
  • Performs other duties as assigned.

    Position Skills and Experience Requirements :

    To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and / or ability required.

  • Bachelor's Degree Business Administration, Engineering or related field required; certification to internal auditing preferred.
  • 5-7 years Quality Management experience, preferably in medical devices required.
  • Strong Analytical ability utilizing Statistical Techniques (AQL / RQL, CPK, GR&R, DOE
  • Experience driving zero PPM in a lean manufacturing environment.
  • Knowledge / experience with ISO 13485 and 21 CFR 820, or equivalent; quality system requirements required.
  • Ability to use MS Office Tools such as Word, Excel, Project (or other project management software), Access and MiniTab (or other statistics software).
  • Ability to build respect / trust within internal staff / other functional leaders as well as external customers.
  • Excellent interpersonal, communication (verbal and non-verbal), and presentation skills.
  • Possesses excellent time management, prioritization abilities, and strong project management skills.
  • Highly motivated, detail-oriented, and eager to drive needed change.
  • Demonstrated ability to autonomously make strategic decisions.
  • Must possess comprehension and reasoning skills used to understand and collect data, interpret technical instructions, and draw valid conclusions.
  • Ability to travel occasionally to other ITW locations and for customer visits.
  • Create a job alert for this search

    Quality Manager • Washington, NC, US

    Related jobs
    Continuous Improvement (CI) Engineer

    Continuous Improvement (CI) Engineer

    Jobot • Washington, NC, US
    Full-time
    Continuous Improvement Engineer / $$$ / RELOCATION OFFERED!!!.This Jobot Job is hosted by : Evan Flynn.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary : ...Show more
    Last updated: 30+ days ago • Promoted
    MANAGER

    MANAGER

    European Wax Center • Greenville, North Carolina, US
    Full-time
    NOW HIRING A MANAGER IN OUR GREENVILLE, NC LOCATION WITH A STRONG BACKGROUND IN SALES, CUSTOMER SERVICE, COACHING, AND TRAINING ! MUST BE ABLE TO WORK 40+ HOURS A WEEK, MORNINGS AND / OR EVENINGS AND...Show more
    Last updated: 11 hours ago • Promoted • New!
    Get Paid to Test Products at Home – Flexible Hours, Weekly Pay

    Get Paid to Test Products at Home – Flexible Hours, Weekly Pay

    OCPA • Belhaven, North Carolina, us
    Part-time +1
    Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...Show more
    Last updated: 30+ days ago • Promoted
    Maintenance Supervisor

    Maintenance Supervisor

    Jobot • Edenton, NC, US
    Permanent
    Nationally Ranked Food Company - Tight Team Culture.This Jobot Job is hosted by : Ray Bahl.Are you a fit? Easy Apply now by clicking the "Apply Now" button and sending us your resume.Salary : $90,000...Show more
    Last updated: 30+ days ago • Promoted
    Maintenance Manager

    Maintenance Manager

    Jobot • Pinetown, NC, US
    Full-time
    Maintenance Manager Role with Industry Leader / $100,000 - $130,000 per year depending on Experience / Excellent Benefits and Room for Growth. This Jobot Job is hosted by : Ken McClure.Are you a fit?...Show more
    Last updated: 30+ days ago • Promoted
    Continuous Improvement Engineer

    Continuous Improvement Engineer

    Jobot • Pinetown, NC, US
    Full-time
    Continuous Improvement Engineer Role with Industry Leader / $75,000 - $95,000 per year depending on Experience / Excellent Benefits and Room for Growth. This Jobot Job is hosted by : Ken McClure.Are ...Show more
    Last updated: 30+ days ago • Promoted
    Test Products from Home – $25-$45 / hr + Freebies

    Test Products from Home – $25-$45 / hr + Freebies

    OCPA • Bath, North Carolina, us
    Part-time +1
    Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...Show more
    Last updated: 30+ days ago • Promoted
    Remote Product Tester – $45 / hr + Free Products – Start Now!

    Remote Product Tester – $45 / hr + Free Products – Start Now!

    OCPA • Bath, North Carolina, us
    Remote
    Part-time +1
    Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...Show more
    Last updated: 30+ days ago • Promoted
    Store Manager in Training (MIT)

    Store Manager in Training (MIT)

    Insomnia Cookies • Greenville, NC, United States
    Full-time
    Insomnia Cookies is actively hiring for a full-time hourly.Store Manager in Training (MIT).Our sweet MIT perks & compensation : . Market competitive hourly compensation.Eligibility for end of period s...Show more
    Last updated: 30+ days ago • Promoted
    Side Hustle Project Lead

    Side Hustle Project Lead

    Finance Buzz • Williamston, North Carolina, US
    Full-time +1
    We’re offering a role for someone who wants to lead their own side-income project in their spare time.You’ll explore various proven side hustles, select the ones that fit your lifestyle, and run th...Show more
    Last updated: 22 days ago • Promoted
    Supervisor(08826) - 139 W. Main Street

    Supervisor(08826) - 139 W. Main Street

    Domino's Franchise • Williamston, NC, US
    Full-time
    Conduct "Pre-planned" Coaching and Mentoring of GMs, AMs and crew.Plan on-the-job coaching objectives before each store visit using store planning tool.Provide "suggestive" on-t...Show more
    Last updated: 30+ days ago • Promoted
    5959 - GxP Quality Auditor / Senior Quality Lead

    5959 - GxP Quality Auditor / Senior Quality Lead

    Verista • Greenville, NC, US
    Full-time
    GxP Quality Auditor / Senior Quality Lead.Verista's 500 experts team up with the world's most recognizable brands in the life science industry to solve their business needs.The nature of our busine...Show more
    Last updated: 29 days ago • Promoted
    Product Tester (Work From Home) – Keep Free Products + Weekly Pay

    Product Tester (Work From Home) – Keep Free Products + Weekly Pay

    OCPA • Belhaven, North Carolina, us
    Remote
    Part-time +1
    Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...Show more
    Last updated: 30+ days ago • Promoted
    5959 - GxP Quality Auditor / Senior Quality Lead

    5959 - GxP Quality Auditor / Senior Quality Lead

    Verista, Inc. • Greenville, NC, US
    Full-time
    The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world's most pressing heal...Show more
    Last updated: 30+ days ago • Promoted
    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,747 to $1,858 per week in Washington, NC

    Travel Registered Nurse (RN) - Intensive Care Unit (ICU) / Critical Care - $1,747 to $1,858 per week in Washington, NC

    TravelNurseSource • Washington, NC, US
    Full-time
    TravelNurseSource is working with Fusion Medical Staffing to find a qualified ICU / Critical Care RN in Washington, North Carolina, 27889!. Facility in Washington, North Carolina.Fusion Medical Staffi...Show more
    Last updated: 2 days ago • Promoted
    Work From Home Product Tester – $25-$45 / hr – No Experience Needed

    Work From Home Product Tester – $25-$45 / hr – No Experience Needed

    OCPA • Mesic, North Carolina, us
    Remote
    Part-time +1
    Product Testers are wanted to work from home nationwide in the US to fulfill upcoming contracts with national and international companies. We guarantee 15-25 hours per week with an hourly pay of bet...Show more
    Last updated: 30+ days ago • Promoted