Quality Assurance (QA) Associate Medical Devices

Quality Assurance (QA) Associate- Medical Devices B-One Ortho, Corp. Fairfield, NJ Job Details Full-time $52,000 - $68,000 a year 1 day ago Benefits Health insurance Dental insurance 401(k) Qualifications Microsoft Excel ISO standards GMP Medical device manufacturing facility experience Continuous improvement Attention to detail Regulatory/legal compliance standards in production Biomedical regulatory compliance Product quality assurance Productivity software Cross-functional communication FDA regulations Full Job Description Position Summary The Quality Assurance (QA) Associate supports and maintains the Quality Management System (QMS) to ensure medical devices are manufactured, tested, released, and supported in compliance with applicable regulations and standards (e.g., FDA 21 CFR Part 820 / QMSR and

ISO 13485

). This role partners cross-functionally with Manufacturing, Research and Development (R D), Supply Chain, and Regulatory to help ensure product quality, patient safety, data integrity, and inspection readiness. Essential Duties and Responsibilities

• Support QMS processes including document control, record retention, and Good Documentation Practices (GDP).
• Review quality records as applicable (e.g., Device History Records, batch/lot records, and inspection records) to support product disposition.
• Support First Article Inspection (FAI) and Quality Inspection Plan (QIP) documentation review and release.
• Support Manufacturing/Production department on quality requirements by providing day-to-day guidance on process adherence, product specifications/drawings, and applicable cGMP/GDP expectations; help resolve documentation or questions to ensure compliant and product disposition readiness.
• Support nonconformance management: initiate records, coordinate investigations, assist with root cause analysis, and ensure timely, compliant documentation and closures.
• Support Corrective and Preventive Action (CAPA) activities, including investigation support, action item tracking, and verification of effectiveness, as assigned.
• Support supplier quality activities such as supplier qualification support, supplier performance monitoring, and review of supplier-provided quality documentation (e.g., CoC, CoA, and CoS, test reports) as applicable.
• Support calibration management activities, including maintaining the equipment calibration schedule, reviewing calibration records/certificates, supporting out-of-tolerance investigations and impact assessments, and ensuring calibration status/traceability requirements are met.
• Assist with Change Management activities by ensuring required quality assessments, documentation updates, and training impacts are identified and completed.
• Support training compliance by coordinating or tracking required training, ensuring curricula and training records are current.
• Participate in metrics and trending (e.g., nonconformances, complaints, CAPA aging) and prepare summaries for management review.
• Perform other duties as assigned to support quality objectives and continuous improvement.

Qualifications /

Requirements:

• Associate's or Bachelor's degree in a scientific/technical discipline (or equivalent combination of education and experience).
• 0-2 years of experience in Quality Assurance/Quality Systems in a regulated industry (medical device, pharma, biotech, or similar).
• Working knowledge of ISO 13485 and FDA medical device quality system requirements (21 CFR Part 820 / QMSR).
• Proficiency with Microsoft Office (Excel, Word, PowerPoint)
• Ability to write clearly and maintain accurate, complete records in accordance with GDP.
• Strong attention to detail and ability to manage multiple priorities.
• Strong communication skills; proven ability to collaborate cross-functionally and contribute effectively to a team environment.
• Knowledge of quality and business system. Preferred Qualifications
• Ability to read, write, and speak Chinese (Mandarin preferred)

Pay:

$52,000.00 - $68,000.00 per year

Benefits:

401(k) Dental insurance Health insurance

Work Location:

In person