Quality Assurance Analyst

Job Summary:

Nutek Bravo is seeking a detail-oriented Quality Assurance (QA) Analyst to join our team. Nutek Bravo is and electron beam sterilization provider servicing the life science industries. The QA Analyst will play a critical role in ensuring compliance with regulatory standards and internal quality systems. This position will primarily focus on batch release, Corrective and Preventive Actions (CAPA), deviation management, and change control processes, ensuring that all products meet the highest standards of safety, quality, and efficacy.

Key Responsibilities:

1. Batch Release

• Review and approve batch records to ensure compliance with regulatory requirements (e.g., FDA, ISO 13485) and internal quality standards.
• Collaborate with production team to resolve any discrepancies or incomplete documentation prior to batch release.

2. CAPA Management

• Investigate non-conformances, customer complaints, and audit findings to identify root causes.
• Work with cross functional team to develop and implement effective corrective and preventive actions to address quality issues.

3. Deviation Management

• Document, review, and assess deviations from standard operating procedures (SOPs) or established processes.
• Conduct risk assessments to evaluate the impact of deviations on product quality and safety.

4. Change Control

• Manage change control requests related to processes, equipment, materials, or documentation.
• Evaluate the potential impact of changes on product quality, regulatory compliance, and operational efficiency.

5. Regulatory Compliance & Documentation

• Ensure SOP compliance with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.
• Support internal and external audits and address audit findings.
• Identify opportunities for process improvement within the QA system to enhance efficiency and compliance.
• Provide training to team members on quality-related processes such as CAPA, deviation handling, and change control procedures.

Required Qualifications:

• Bachelor’s degree in Science, Engineering, or a related field (or equivalent experience).
• 1+ years of experience in Quality Assurance within a life science industry.
• Excellent attention to detail with strong analytical skills for problem-solving and root cause analysis.
• Effective communication skills to collaborate with cross-functional teams and present findings clearly.
• Ability to prioritize tasks in a fast-paced environment while maintaining accuracy.

Preferred Qualifications:

• Proficiency using electronic Quality Management Systems (eQMS).
• knowledge of FDA regulations (21 CFR Part 820), ISO 13485 standards, and other relevant guidelines for medical devices.
• Experience with CAPA management systems, deviation investigations, change control processes, and batch release activities.
• Familiarity with sterilization validation processes (e.g., VDmax25 or other dose-setting methods) is a plus.
• Certification in Quality Management Systems (e.g., CQE or CQA) is a plus.