Quality Assurance Specialist

This is an exciting opportunity to join a growing company that focuses on precise, early detection of emerging diseases. The Quality Assurance Specialist ensures products, processes, and documentation meet established quality standards and comply with applicable regulatory requirements. This role blends regulatory submissions and strategy with quality system implementation, auditing, and continuous improvement to support product approvals, market access, and patient safety.

Responsibilities

• Develop, implement, and maintain the Quality Management System (QMS).
• Plan, conduct, and coordinate internal and supplier audits to ensure compliance with regulatory and accreditation standards (e.g., CLIA, CAP).
• Manage document control, change control, CAPA, nonconformance management, complaint handling, and MDR/Vigilance activities.
• Coordinate proficiency testing programs and analyze results to identify trends and improvement opportunities.
• Ensure all required regulatory licenses and accreditations remain current.
• Maintain quality documentation, SOPs, and laboratory testing procedures.
• Prepare, analyze, and present quality metrics and reports for management review.
• Train and onboard new personnel; review training documentation and monitor ongoing competency of testing staff.
• Maintain working knowledge of laboratory protocols, specimen processing, equipment operation and maintenance, and data analysis.
• Review and approve product labeling, packaging, promotional materials, and technical documentation for regulatory compliance.
• Monitor changes in global regulations, standards, and guidance; assess impact and recommend updates to internal processes.
• Partner with cross-functional teams (R&D, manufacturing, engineering, clinical, marketing) to embed quality and regulatory requirements early in product development.
• Lead or support management reviews, regulatory and quality training programs, and continuous improvement initiatives.
• Prepare, submit, and maintain regulatory filings, documentation, and reports.
• Coordinate with regulatory and accreditation bodies to support product approvals, certifications, and inspections.
• Ensure compliance with internal health and safety policies; report and address violations as required.
• Participate as an external auditor on College of American Pathologists (CAP) inspection teams, as required by the CAP accreditation program.
  
  

Requirements And Desired Experience

• Bachelor's degree (required) in life sciences, biology, chemistry, engineering, pharmacy, or related field; Master's a plus
• 3 years of laboratory experience, including experience with audits, compliance systems, and regulatory submissions.
• Strong knowledge of key regulations and standards: FDA QSR (21 CFR Part 820/211), ISO 13485/9001, EU MDR/IVDR, GMP, ICH guidelines, etc.
• Working knowledge of relevant regulatory frameworks
• Professional certification is a plus (i.e, Regulatory Affairs Certification – RAC, ASQ Certified Quality Auditor – CQA).
• CLS Generalist or CGMBS license preferred
• Proven knowledge of quality assurance terminology, software, methods, and tools.
• Previous experience with Laboratory Information Management Systems is preferred.
• Proficient in QMS software (i.e. MediaLab, TrackWise, MasterControl or similar)
• Strong analytical, problem-solving, and decision-making skills.
• Experience in compliance and/or regulatory and knowledge of laboratory standards and regulations
• Experience with Microsoft Office Suite; Word, Outlook, Excel
• Excellent written and verbal communication skills for agency interactions, technical writing, and cross-functional collaboration.
• Able to effectively present information and respond to questions from various stakeholders
  
  

Compensation (DOE): $80,000 - $95,000 annual salary