Quality Systems Specialist

Description

Summary

The Quality Systems Specialist performs a variety of complex quality-specific duties and supports the Quality Systems Department. This role is responsible for monitoring, coordinating, and performing quality assurance activities, quality control, and auditing. The Quality Systems Specialist supports and executes performance improvement activities to ensure regulatory and accrediting agency compliance as they pertain to internal policies, procedures, and practices, organizational goals, and industry standards, regulations, and guidance.

Essential Duties & Responsibilities

• Quality Assurance and Control:
  • Perform internal organizational risk analysis to identify quality assurance activities, including quality control monitoring and internal auditing.
  • Implement the annual audit schedule of the quality audit process to ensure compliance with policies, procedures, and practices guided by industry standards, regulations, and guidance.
  • Lead internal audit processes of operational departments' quality control checks.
  • Perform external audits, including critical supplier initial qualification audits, routine critical supplier audits, and focused supplier audits resulting from Supplier Corrective Action Reports (SCAR).
  • Report occurrences such as deviations and SCARs identified during audits and ensure completion of quality reviews and closure of these occurrence reports.
  • Review management investigations, including evaluation of corrective actions, preventative actions (CAPA), root cause analyses (RCA), effectiveness checks, and verification of effectiveness (VOE).
• Supplier Management:
  • Maintain the supplier program with oversight and support from the Manager, Quality Systems.
  • Develop supplier qualifications for critical and non-critical suppliers, review contractual agreements, and ensure all appropriate certifications, licensures, and registrations are current.
  • Ensure the supplier list, including contacts, is up to date.
• Quality Management System (QMS):
  • Administer quality surveillance and application of the QMS software to ensure control of policies and procedures.
  • Collaborate with the Manager, Quality Systems, and operational leadership to ensure the document lifecycle and content are compliant with organizational practices and standards.
  • Complete the final quality review within the QMS centralized repository for documents and attachments prior to activation.
• Performance Improvement:
  • Support and execute performance and process improvement activities using continuous improvement methodologies.
  • Analyze key performance indicators (KPIs) for advantages and disadvantages, including calculating the Cost of Quality (CoQ) and the Cost of Poor Quality (CoPQ) for operational changes.
  • Other duties as assigned.

Qualifications

Qualifications, Education & Experience

• BS degree.
• Knowledge of industry-specific regulations (AATB, FDA, CMS, UNOS/OPTN).
• Prior experience of proven quality success.
• Quality certification(s) preferred, such as American Society for Quality (ASQ) or equivalent.
• Demonstrates analytical and critical thinking skills, with the creative ability to apply knowledge and expertise.
• Self-directed and motivated.
• An equivalent combination of education and experience.