Quality System Specialist

The Quality Systems Specialist is a key contributor to quality assurance, tasked with developing and managing robust processes for investigations, deviation tracking, change control, and CAPA management. This role ensures compliance with industry standards while driving continuous improvement initiatives across the organization.

Key Responsibilities

• Conduct thorough investigations to determine root causes of deviations or nonconformances, collaborating with Subject Matter Experts (SMEs) across departments.
• Design and document change controls, deviations, and CAPAs, providing assessments of risks and impacts to processes and product quality.
• Provide troubleshooting assistance and support for electronic Quality Management Systems (eQMS).
• Maintain and analyze Quality Management System metrics to assess process health, identify trends, and recommend improvements.
• Lead discussions with auditors and inspectors regarding quality events, assessments, and outcomes.
• Offer expertise in the review and planning of deviations, change controls, and CAPAs.
• Serve as the Quality liaison to clients, ensuring timely communication, reporting, and coordination with internal SMEs to meet Quality Event timelines.

Skills & Competencies 

• Build strong, customer-centric relationships with internal and external stakeholders, ensuring collaboration and alignment with quality standards.
• Demonstrate exceptional written and verbal communication skills, effectively articulating complex quality issues to diverse audiences.
• Strong understanding of deviation investigation, root cause analysis, risk assessment, change management, and CAPA processes.
• Proficiency with eQMS platforms, Microsoft Office (Word, Excel, PowerPoint, and Visio), and metric development tools.
• Thrive in a collaborative environment while maintaining the ability to manage tasks autonomously.
• Ability to influence and guide process owners toward positive outcomes and compliance improvements.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Experience:
  • 5+ years in a regulated industry.
  • 3+ years managing Quality Systems processes, including Deviations, Change Controls, and CAPAs.
  • Proven track record in internal customer service and cross-functional collaboration.
• Skills:
  • Advanced proficiency in Microsoft Word and Excel.
  • Ability to lift up to 50 lbs and stand for moderate periods.

Preferred Qualifications

• Experience with electronic Quality Management Systems, including administrative roles.
• Public-facing customer support, troubleshooting, or presentation experience.
• Direct involvement in regulatory audits or inspections.
• Certifications in Risk Assessment, Root Cause Analysis, or Investigation Management.
• Microsoft Office Specialist or Expert certification in Word or Excel.