Position Summary: The Quality Engineer II is responsible for supporting and enhancing the site's Quality Management System (QMS) and ensuring regulatory compliance for all serum-related products. This role plays a key part in product quality assurance, regulatory collaboration (including USDA), and quality project management. You’ll interface with internal teams, suppliers, regulatory bodies, and customers to uphold standards aligned with 21 CFR 820, ISO 13485, cGMPs, and internal QMS procedures. Key Responsibilities: Regulatory & Compliance
Ensure site compliance with all relevant and evolving regulations (e.g., QSRs, 21 CFR 820, ISO 13485, import/export laws). Collaborate with the USDA and other regulatory agencies to ensure compliance in areas such as product approvals, safety testing, quarantine, and traceability. Quality Systems Support Maintain and improve the ISO 13485-based QMS. Manage CAPA, nonconformance, product disposition, and inspection activities.Review and revise procedures, forms, and specifications to support continuous improvement. Perform and support internal audits and assist with external audits (supplier, customer, regulatory). Custo
mer & Documentation Support Serve as a technical and regulatory liaison to customers. Manage the Quality Help Desk, including complaints, technical surveys, and customer documentation (e.g., certificates, questionnaires). Develop product master files in line with quality and customer requirements. Process
& Performance Monitoring Track and trend QMS data to support decision-making and improvement initiatives. Assist in product and process evaluations, problem resolution, and performance verification. Support quality training initiatives. Required Qualifications: Education: Bachelor's degree in Biology, Chemistry, Bioengineering, Engineering, or a related scientific field. Experience:
3+ years of Quality or Regulatory experience in medical device, pharmaceutical, or biotech industry. Strong working knowledge of 21 CFR 820, ISO 13485, GMP regulations. Required Skills & Competencies: Solid experience with CAPA, QMS auditing, Change Control, Nonconformance, and Complaint handling. Ability to author and train on SOPs, perform root cause analysis, and support investigations. Familiarity with continuous improvement tools (Lean, Six Sigma). Proficient with Microsoft Office Suite. Preferred Qualifications: Experience with SAP, EtQ, PeopleSoft, or other QMS/ERP systems. Exposure to animal by-product regulations, import/export procedures. Background in virology, immunology, or epidemiology. Experience with statistical analysis and/or project management. Soft Skills: Highly organized with strong attention to detail. Able to prioritize and multitask effectively in a fast-paced environment. Strong interpersonal and communication skills. Able to work independently with minimal supervision and collaborate cross-functionally. Education: Bachelors Degree