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Senior Supplier Quality ngineer

Integer Holdings Corporation
Chaska, MN Full Time
POSTED ON 2/4/2025
AVAILABLE BEFORE 5/3/2025

Job Description Summary

The primary purpose of this position is to develop the risk-based supplier management process, lead the critical supplier-related projects, and support daily supplier non-conformances and requests for change. This position will also be responsible for performing GMP / ISO audits on suppliers, proposing improvements to their quality system and tracking the closure of any audit related non-conformance.

Essential Duties & Responsibilities :

  • Improve supplier quality performance for assigned suppliers.
  • Manage supplier audit program and overall supplier approval / rating program through robust qualification processes.
  • Assure supplier compliance to Lake Region Medical QMS and regulatory requirements through supplier monitoring process.
  • Manage the supplier process change process.
  • Develop positive relationships and work closely with Engineering and Supply Chain to manage and implement supplier / engineering changes, New Product Introductions, and transfers.
  • Interface with Suppliers, Engineering, Operations and Supply Chain to drive Quality improvements that minimize the Costs of Quality, specifically Incoming Rejects, Failures, and operational defects.
  • Work with product support teams on component quality issues and supplier initiatives.
  • Work directly with vendors under the control of the Lake Region Medical QMS. This involves travel to supplier sites so this person must be available to travel at short notice.
  • Support implementation of initiatives such as “Supplied Data” and “Dock to Stock”.
  • Assure Corrective and Preventive Action plans are developed and executed at assigned suppliers in compliance with the CAPA process.
  • Develop and support Supplier Quality Engineering program.
  • Review document and procedure changes for quality requirements and compliance with the quality system.
  • Provide quality support for the disposition of material.
  • Support the implementation of continuous improvement initiatives for productive processes.
  • Comply with all work rules including those pertaining to safety, health, and quality.
  • Provide leadership and guidance to QC Technicians who perform receiving inspection activities.

Job Requirements Minimum Education :

  • Bachelor’s degree in Engineering.
  • Master’s degree strongly preferred.
  • Six Sigma Black Belt Certified or Certified Quality Engineer preferred.
  • Minimum Experience :

    7-10 years experience in Quality, Supplier Quality, Supply Chain or related process driven field.

    Specialized Knowledge :

  • Negotiating, influence and leadership abilities.
  • Computer knowledge : MS Excel, MS Word, MS Power Point, Minitab.
  • Quality System Audits knowledge.
  • Good manufacturing and documentation practices.
  • Drawings and blueprints knowledge.
  • Strong experience with ISO 13485,QSR, and / or ISO9001 systems
  • ASQ certified quality engineer / manager desired
  • ASQ or equivalent auditor certification desired
  • Must have the ability to interact professionally, with associates at all levels of the organization.
  • Keyboarding required for inputting and analyzing data, memorandums and reports.
  • Self-started with the ability to facilitate activities with little direction
  • Deadline sensitive with a high degree of concentration.
  • Attention to details.
  • Must be able to work with diverse groups within the company.
  • Must be able to think critically about technical matters that may impact upon the fit, form or function of Lake Region’s product.
  • High visual and tactile demand.
  • Special Skills :

  • Measurement and test equipment knowledge.
  • Excellent communication (written and verbal) skills with internal and external customers.
  • Presentation skills.
  • Ability to work in a matrix organization, strong analytical skills. Problem solving and skills.
  • Proven leadership, communication, and project management.
  • Demonstrated ability to lead team activities. Strong ability to coach.
  • Advanced problem solving skills.
  • Strong communication, presentation, follow-through, and organizational skills.
  • Ability to effectively work with coworkers and all levels of the organization
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