Quality Systems Specialist - Laboratory

Quality Systems Specialist supports laboratory operations for medical device testing, ensuring processes meet regulatory requirements and quality standards. The role maintains compliance with corporate policies and industry regulations while driving continuous improvement and operational excellence.

Responsibilities

• Coordinate and maintain laboratory quality systems aligned with regulatory requirements
• Serve as local subject matter expert for quality compliance and guidance
• Lead implementation of quality objectives and key business drivers for laboratory operations
• Drive continuous improvement initiatives using metrics, lessons learned, and best practices
• Oversee training programs, audits, LIMS operations, and complaint investigations

Requirements

• Bachelor's degree in chemistry, microbiology, or related laboratory science
• 2 years laboratory experience in regulated industry
• Knowledge of ISO 13485, ISO 17025, and 21 CFR Part 820
• Proficiency with Excel, Word, PowerPoint and similar tools
• Strong organizational, analytical, and process efficiency skills
• ASQ Certified Quality Engineer or Quality Auditor certification preferred