Quality Manager in Washington, NC at ITW Medical

Date Posted: 11/9/2018

Job Snapshot

Job Description

ITW Description:

Founded in 1912, Illinois Tool Works Inc. (NYSE: ITW) is a diversified, Fortune 200 manufacturing company that delivers specialized expertise, innovative thinking and value-added products to meet critical customer needs in a variety of industries. Ranked among Fortune’s Magazine’s most admired companies, the company focuses on solid growth, improving profitability and strong returns across its worldwide platforms and divisions. These divisions serve customers and markets around the globe, with a significant presence in developed as well as emerging markets. ITW’s revenues totaled $13.6 billion in 2016.

Division Description:

ITW Medical manufactures and sells components and finished devices for use in Medical Imaging, Filtration, Infusion, and Minimally Invasive applications. The division serves as a tier 1 supplier to large medical device companies such as Medtronic, Abbott, etc. ITW Medical operates in 6 locations (US, Mexico, Ireland) with 500 employees.

Position Summary:

This position:

  • Utilizes data to drive corrective, preventive, and continuous improvement actions.

  • Champions the use of the Quality System to ensure compliance with regulatory requirements to ensure the continuous manufacture of products consistent with established customer and internal requirements.

  • Follows business and safety guidelines.

  • Assists, as needed, in other areas of business/manufacturing.

  • Manages direct reports to support their efforts with their quality functions.

    Essential Job Duties and Responsibilities:

  • Drive Corrective, Preventive and Continuous Improvement Actions, including acting as Customer Representative.

  • Act as direct contact for customer quality related issues; coordinate course of action for alleviating and resolving concerns and providing timely responses.
  • Ensure Management reviews are conducted to provide for systems review.
  • Manage Internal Audit Program.
  • 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 CAPACIAs, Alerts, and other relevant documents.
  • Ensure Root Cause Analyses are conducted to establish reasons and solutions for Quality matters.
  • Maintain the ISO 13485 Quality Management System, including providing training support.
  • Effectively interact with Production and Development teams to

  • Maintain product supply.
  • Help introduce new products, including quality planning.
  • Oversee sampling inspection and testing of received parts, components, and materials to determine conformance to standards and customer requirements.
  • Use logic, knowledge, and skills to oversee QA/QC activities throughout manufacturing location and of direct reports.
  • Use charts/data for scheduled meetings and conduct/participate in meetings as appropriate.

  • Supervise direct reports.

  • Work with the Quality team that is able to handle the day to day production activities with minimal direct supervision and guidance.

  • Offer input for areas for improvement in products, processes and procedures.

  • Support Sales/Engineering/Management with special projects.

  • Performs other duties as assigned.

ITW offers a competitive compensation and benefits package, including competitively priced medical and dental coverage the first of the month following hire, free life insurance, paid vacation and holidays, and immediate 401k matching. Additional retirement savings contribution (above and beyond 401k) is awarded at no cost after one year.

Job Requirements

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.

Educational Level

  • 4-year quality, technical, or related degree and 2 years medical device experience
  • Certification to internal auditing preferred

Comprehension/Reasoning Skills

  • Ability to read and understand common scientific and technical journals.

  • Ability to correspond with co-workers, customers, and vendors.

  • Ability to effectively present information (orally and in writing) to top management, customers, and vendors.

  • Ability to define issues, collect data, establish facts, draw valid conclusions, and apply principles or logical scientific thinking to address a wide range of intellectual and practical issues.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with a variety of abstract and concrete variables.

Math Skills

  • Ability to apply advanced mathematical concepts and theory such as geometry, statistics, algebra, calculus, and differential equations to address engineering issues.

Other Skills and Abilities

  • Experience in medical device manufacturing environment.

  • Knowledge/experience with ISO 13485 Quality Standard and CFR 820 regulatory requirements.

  • Excellent verbal and nonverbal communication skills.

  • Attention to detail, dedication, strong work ethic, good communication skills, time management abilities, team player, flexibility/adaptability, and strong interpersonal skills are needed.

  • Computer skills: Personal computer use, including Microsoft Office, statistics software, and project management. Microsoft Access experience preferred.

  • Experience managing/supervising direct reports.

  • Ability to travel.

Physical Demands

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • While performing the duties of this job, the employee is occasionally required to stand; walk; and regularly use hands to finger, handle, or feel objects, tools, or controls. The employee occasionally is required to reach with hands and arms; and frequently talk or hear. 

ITW Medical is an equal opportunity, equal employment, affirmative action employer. We strive to create a diverse and inclusive work environment where everyone is welcome to contribute their unique talents and ideas. We encourage applications from females, males, disabled/protected or other veterans, persons with disabilities, all races and ethnicities, sexual orientations and gender identities. Reasonable accommodation will be made to enable persons with disabilities to apply and to perform the essential job functions. If you require assistance with completing an application, please reply that you require assistance.

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