Quality Assurance Specialist I

Nova Biomedical: One Global Brand. One Vision. Together under one name. Advanced Instruments and Nova Biomedical are now united under one brand, Nova Biomedical, marking a major milestone in our journey to deliver greater value to our customers. By combining our strengths, we're accelerating innovation, supporting critical workflows, and delivering world-class service across the biopharmaceutical and clinical markets. 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. Responsibilities 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 Experience Requirements 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 within medical device, IVD, pharmaceutical, biotechnology, or similar regulated industries preferred Equivalent combination of education and experience may be considered Physical Requirements And Working Conditions 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 Why Work for Nova Biomedical Flexible Medical, Dental, & Vision Coverage Competitive 401k company match Bonus Program, Generous PTO and paid holidays Generous Tuition reimbursement Hybrid and flexible work arrangements Professional development, engagement and events Company marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME offices Company subsidized cafeteria in our Waltham, MA office Hybrid work schedule on-site in Billerica, Manning Rd Targeted Salary Range: $77,000 - $86,000/year. Nova Biomedical believes in transparency and integrity throughout all we do, including compensation. The provided salary range for this role represents the expected base salary or hourly rate for this opening. Actual compensation will be commensurate with the candidate’s experience and may vary based on individual factors such as location, skills, and education. At Nova Biomedical, we’re not just building instruments, we’re powering breakthroughs that improve lives. Our smart, science-driven solutions are trusted in over 100 countries to speed drug development and enhance patient care. Our integration brings together more than 70 years of scientific excellence with Nova’s cutting-edge innovation, forming a powerhouse of precision, purpose, and possibility. With FDA-registered, ISO-certified manufacturing, more than 125 FDA approvals, and industry-trusted diagnostics, we’re setting new standards in quality and reliability. Nova Biomedical is proud to be a global leader in osmolality testing and biotechnology and in vitro diagnostic (IVD) instrumentation, dedicated to advancing patient care and scientific discovery with a legacy that continues to shape the future of life sciences. With headquarters in Norwood and Waltham, Massachusetts, and a global team of nearly 2,000 employees, we’re building a collaborative, empowered culture grounded in shared values: Customer Centricity, Ingenuity, Ownership & Accountability, Collaboration, and Integrity. Working at Nova Biomedical means joining a mission-driven organization where your contributions matter. Whether you're in engineering, science, manufacturing, or support, you’ll be part of a team that values innovation, invests in your growth, and is committed to making a real-world impact on global health. Explore what’s next with us at novabiomedical.com EEO Statement Nova Biomedical takes pride in being an equal opportunity employer committed to hiring a diverse and inclusive workforce. As a 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. Privacy policy #J-18808-Ljbffr Nova Biomedical