Quality Assurance Specialist

Quality Assurance SpecialistAdvanced 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.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 proceduresManage the Documents of External Origin program, including monitoring, review, distribution, maintenance, and impact assessments of applicable regulations and standardsReview quality records for completeness, accuracy, and compliance with Good Documentation Practices (GDP) and retention requirementsProvide administrative support for equipment calibration and preventive maintenance programs, including tracking and reportingSupport preparation and execution of external audits and inspections, including record coordination and evidence retrievalConduct internal quality audits and support closure of findings and actionsInitiate, revise, and review controlled documents including SOPs, work instructions, forms, and templatesPrepare and review Engineering Change Orders (ECOs), Manufacturing Variances (MVs), and other controlled changesSupport quality system processes such as CAPA, nonconformance, investigations, and shipping holdsTrack deliverables, actions, and due dates to ensure timely completion of quality activitiesIdentify and escalate documentation gaps, procedural issues, and compliance concernsSupport employee training related to QMS procedures and complianceCollaborate with cross-functional teams including Manufacturing, Engineering, Regulatory Affairs, Quality Control, Supplier Quality, Supply Chain, Technical Support, and R&DPerform other quality system and compliance-related duties as assignedExperience Requirements:Bachelor's degree in a scientific, technical, business, or related discipline preferred3–5 years of experience in Quality Assurance, Quality Systems, Regulatory Compliance, Document Control, or a related function in a regulated industryExperience supporting QMS, audits, change control, and compliance activities preferredExperience within medical device, IVD, pharmaceutical, biotechnology, or similar regulated industries preferredEquivalent combination of education and experience may be consideredPhysical Requirements and Working Conditions:Ability to review documents in both electronic and paper formatsAbility to use required PPEAbility to access manufacturing, warehouse, laboratory, and office environmentsAbility to travel between local U.S. facilities as neededAbility to sit, stand, walk, and use a computer for extended periodsAbility to lift and carry up to 25 poundsWhy Work for Nova BiomedicalFlexible Medical, Dental, & Vision CoverageCompetitive 401k company matchBonus Program, Generous PTO and paid holidaysGenerous Tuition reimbursementHybrid and flexible work arrangementsProfessional development, engagement and eventsCompany marketplace for lunch and snacks in our Norwood, MA, Billerica, MA and Westbrook, ME officesCompany subsidized cafeteria in our Waltham, MA officeWork Location: Hybrid work schedule on-site in Billerica, Manning RdTargeted 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.comEEO 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.