Quality Assurance Specialist

Job Summary

The Quality Assurance (QA) Specialist supports the effectiveness, compliance, and continual improvement of the Quality Management System (QMS) by coordinating key quality processes. This role works cross-functionally to maintain an inspection-ready QMS, ensure compliance with regulatory and quality requirements, support implementation of external requirements, and drive continuous improvement initiatives that enhance overall quality system performance and operational effectiveness.

• Support the maintenance and improvement of the QMS to ensure compliance with regulatory requirements, industry standards, and internal procedures
• Manage the Documents of External Origin program, including monitoring, review, distribution, maintenance, and impact assessments of applicable regulations and standards
• Review quality records for completeness, accuracy, and compliance with Good Documentation Practices (GDP) and retention requirements
• Provide administrative support for equipment calibration and preventive maintenance programs, including tracking and reporting
• Support preparation and execution of external audits and inspections, including record coordination and evidence retrieval
• Conduct internal quality audits and support closure of findings and actions
• Initiate, revise, and review controlled documents including SOPs, work instructions, forms, and templates
• Prepare and review Engineering Change Orders (ECOs), Manufacturing Variances (MVs), and other controlled changes
• Support quality system processes such as CAPA, nonconformance, investigations, and shipping holds
• Track deliverables, actions, and due dates to ensure timely completion of quality activities
• Identify and elevate documentation gaps, procedural issues, and compliance concerns
• Support employee training related to QMS procedures and compliance
• Collaborate with cross-functional teams including Manufacturing, Engineering, Regulatory Affairs, Quality Control, Supplier Quality, Supply Chain, Technical Support, and R&D
• Perform other quality system and compliance-related duties as assigned

• Bachelor’s degree in a scientific, technical, business, or related discipline preferred
• 3–5 years of experience in Quality Assurance, Quality Systems, Regulatory Compliance, Document Control, or a related function in a regulated industry
• Experience supporting QMS, audits, change control, and compliance activities preferred
• Experience with in medical device, IVD, pharmaceutical, biotechnology, or similar regulated industries preferred
• Equivalent combination of education and experience may be considered

• Ability to review documents in both electronic and paper formats
• Ability to use required PPE
• Ability to access manufacturing, warehouse, laboratory, and office environments
• Ability to travel between local U.S. facilities as needed
• Ability to sit, stand, walk, and use a computer for extended periods
• Ability to lift and carry up to 25 pounds

Targeted Salary Range: $77,000 - $86,000/year.

Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As part of our commitment to a diverse and inclusive workforce, Nova Biomedical will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.