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Quality Team Leader - Kirksville, MO

Date Posted: 2/12/2021

Job #1580254
Kirksville, Missouri

* This company is specifically seeking candidates with military experience. *


Job Description & Responsibilities:

Effectively manage inspection resources so as to insure that only quality products are released for distribution, meeting all regulatory requirements.  Efficiently manage resources to support change management systems such as protocol studies and approval submissions.  Maintain adequate control of  certified processes, suppliers, environments, instrumentation, record/samples, calibration, sterile products, complaints and the QA Document Center.

  • Management of day to day inspections in both In-Coming and In-Process testing laboratories.  Ensuring adequate resources are available to support engineering projects and production requirements.  Support team and promote execution of inspections in a timely manner in support of customer service.
  • Support Production System initiatives.
  • Direct supervision of hourly workforce in a union environment.
  • Produce graphs and charts for plant metrics.  Monitor SAP entries for accuracy and data entry.
  • Perform Internal Audits and Supplier Audits (Become ISO13485 Lead Auditor)
  • Participate on teams in support of Global Quality and Supplier Quality.
  • Monitor sterilization results in conjunction with the Quality Systems Administrator and provide support to that role during vacations and absences.
  • Monitor calibration requirements and ensure they are done correctly and on time.
  • Create and approve specification changes as required.
  • Approve FTIR scans for resins and plastic materials.
  • Perform investigations for customer complaints – including the gathering of data from SAP for lot trace and retrieval of production / inspection forms for product.  Handles updating QN’s in SAP as necessary.
  • Support MyQumas and SAP questions and assist personnel with issues and problems.
  • Create Certificates of Conformance for Regulatory on request and for sterile products, products shipping to customers and sister plants.  Some require graphs charting the inspection data also.
  • Support plant initiatives and goals
  • Support production on a daily basis with quality decisions and guidance
  • In conjunction with the Supply Chain Specialist perform Supplier Evaluations internally on a quarterly basis.
  • Oversee the quality aspects of sterile product inspections and releases; oversee QA Document center.

Education and Work Requirements:

  • Bachelor degree (Science field preferred)
  • 2+ years Supervision of direct reports or similar experience
  • Experience in medical device or pharmaceutical field preferred; auditing experience (preferred)

Title: Quality Team Leader

Location: Kirksville MO

Client Job ID: 1580254

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