Quality Assurance Engineer II

The Quality Assurance Engineer II is responsible for ensuring the quality, reliability, and performance of software products through systematic testing and quality practices.

This role works closely with developers, product managers, and other stakeholders to design, execute, and improve test strategies while contributing to continuous improvement of QA processes.

The QA Engineer II independently handles moderately complex testing efforts.

• Ensure compliance with cGMP, ISO 9001, ICH Q7/Q10, and relevant FDA/EMA regulatory requirements.
• Support development, review, and revision of SOPs, work instructions, and batch records.
• Lead customer complaints process.
• Perform QA review and approval of manufacturing documentation, including batch production records, logbooks, change controls, and deviations.
• Support internal and external audits; facilitate corrective and preventive actions (CAPA).
• Evaluate production processes for compliance, robustness, and consistency.
• Participate in process risk assessments (FMEA, HACCP, HAZOP).
• Support equipment qualification and facility validation activities (IQ/OQ/PQ).
• Review and verify analytical data, lab test results, or in‐process quality checks.
• Ensure raw materials and finished products meet specifications.
• Lead or support investigations of deviations, nonconformities, and OOS/OOT results.
• Perform root-cause analyses and identify corrective/preventive actions.
• Collaborate with cross‐functional teams (Manufacturing, Engineering, QC, Validation, etc.).
• Identify opportunities to improve quality performance, reduce cycle time, or enhance process control.
• Participate in Lean, Six Sigma, or operational excellence initiatives.
• Contribute to quality metrics reporting and trend analysis.
• Provide training and technical guidance on quality procedures, compliance expectations, and good documentation practices.
• Assist in onboarding and mentoring new team members.
• Interface with Internal and External Customers, Suppliers and Regulatory Agencies.