Quality Tech Services, LLC
  • Bloomington, MN, USA
  • Salary
  • Full Time

Medical, dental, vision, life insurance, 401(k), paid time off


Customer Quality Coordinator Ideal Candidate Profile

QTS is currently seeking an energetic, responsive and well-organized Full Time Customer Quality Coordinator. This position is responsible for providing QA support to the designated Business Unit team. It will also perform sterile documentation review and product release. It will also be responsible for providing support for customer audits,  questionaires, complaints, Nonconforming Material Reports (NCMRs) & Corrective and Preventative Actions (CAPAs), and Quality System information requests. An ideal candidate will have the ability to successfully multi-task and adapt to change in our fast-paced, dynamic environment.

 

Customer Quality Coordinator Job Summary

Business Unit Support

  • Provide the Business Unit team guidance related to meeting the QTS Quality Management System.
  • Manage complaints, NCMRs and CAPAs.
  • Perform internal and supplier quality audits, as required.
  • Manage customer audits of QTS.
  • Review first time product builds.

Customer Support

  • Monitor sterilization and testing requirements/events for customers (dose audits, bioburden testing, etc.)
  • Actively involved in reviewing and ensuring customer requirements are understood and accurately reflected in QTS manufacturing related procedures.

Documentation Responsibilities

  • Perform customer-related document change request (DCR) reviews for meeting the QTS system and the customer requirements
  • Review inspection templates for accuracy to drawing specifications and requirements.
  • Perform sterile document reviews and product release (Certificate of Compliance.)

 

Customer Quality Coordinator Skills and Experience

  • Skills and knowledge equivalent to those obtained in a technical program or certificate related to the Quality Field.
  • 3 years' experience in related field.
  • Computer proficiency and attention to detail.
  • Internal audit experience or training.
  • Knowledge or training pertaining to FDA and ISO regulations.
  • Knowledge of blueprint reading and a basic understanding of dimensions and tolerances.

Desirable Criteria & Qualifications

  • Familiar with sterilization practices.
Quality Tech Services, LLC
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