Quality Coordinator

Summary:   Responsible for maintaining quality documents and coordinating quality activities to help maintain an effective Quality Management System.

Essential Duties and Responsibilities:    

  • Creates and maintains Quality System documents such as Standard Operating Procedures (SOP), work instructions, forms, and references.
  • Performs and leads Document Control activities.
  • Ensures accuracy of DHR documents after production.
  • Gathers certifications for shipments to customers.
  • Assists with customer documentation requests and issues.
  • Coordinates and conducts ISO training; maintain training matrix and records.
  • Assists Quality Manager with product and process investigations.
  • Assists with Device Master Record maintenance.
  • Maintains Approved Supplier List.
  • Supports internal audits and in-house external audits.
  • Assists with management of SCARs.
  • Performs trend analysis.
  • Maintains a professional working relationship and effectively communicates with all employees, managers, vendors, customers, and regulatory agencies.
  • Understands and complies with company policies and procedures, regulatory requirements, and safety regulations.
  • Regular attendance at work is required.
  • Performs other assignments as necessary.

Qualifications: 

  • High school diploma or general education degree (GED); one year or more related Quality experience and/or training; or equivalent combination of education and experience.
  • An understanding of ISO 9001/QSR quality system requirements preferred.
  • Requires excellent computer/data entry skills, attention to detail and organizational skills.