Quality Assurance Specialist

10 hours ago


West Chicago, Illinois, United States Barton Staffing Solutions Full time
Job Overview

Barton Staffing Solutions is seeking an experienced Quality Assurance Specialist to join their team. As a key member of the quality team, you will be responsible for ensuring the effective implementation of Quality Management Systems (QMS) and leading continuous improvement initiatives.

Key Responsibilities
  • Liaise with the Quality Manager to support Quality System initiatives, including Change Control, CAPA, Complaints, and Internal/External Audits.
  • Lead continuous improvement initiatives to ensure the QMS is implemented effectively by trending data and using metrics to analyze performance.
  • Support the Change Control Program by assessing Quality Assurance tasks and impacts of operational and product changes.
  • Provide guidance to junior level Specialists on complex issues, assist with onboarding trainings, and review the work of Specialists prior to delivery to a manager.
  • Provide guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements.
  • Research part numbers, drawings, ECOs, etc. as requested/required.
  • Research problems related to controlled documents by using available resources, including current masters, obsolete masters, engineering card files, ECO binder, computer ECO Log, Master Document Distribution List, etc.
  • Create or assist document owners in creating Document Change Requests (DCR) and/or Engineering Change Orders (ECO) and the associated file.
  • Execute implementation actions as required for DCR and ECOs.
  • Close DCR and ECOs after verifying that they are complete.
  • Compare redlines to complete engineering drawings, BOMs, literature, and other documents for accuracy.
  • Assist in preparing and executing external audits as required.
  • Perform other tasks as assigned.
Requirements
  • Experience working in regulated environments and knowledge of applicable regulations/standards including 21CFR820, ISO 13485, cGMPs, FDA Guidelines.
  • Ability to read engineering drawings.
  • Ability to use available resources to track document history and to research problems.
  • Excellent written English skills.
  • Good computer skills. Ability to use Word, Excel, and MS Outlook.
  • Excellent attention to detail.
  • Excellent skills in organization.
  • Ability to travel internationally.
Preferred Qualifications
  • B.A. Degree in a related field, or equivalent work experience, preferred.
  • 8 years of experience, preferred.


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