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 escalate 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
Work 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.
