Quality Assurance Analyst, Healthcare

Our client is seeking a detail-oriented and proactive Quality Assurance Analyst, Healthcare to join their team at an electron beam sterilization facility specializing in medical devices.

This position 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:

Batch Release

• Review and approve batch records to ensure compliance with regulatory requirements (e.g., FDA, ISO 13485) and internal quality standards.
• Verify sterilization process parameters and sterility assurance levels (SAL) for each batch.
• Collaborate with production teams to resolve any discrepancies or incomplete documentation prior to batch release.

CAPA Management

• Investigate non-conformances, customer complaints, and audit findings to identify root causes.
• Develop and implement effective corrective and preventive actions to address quality issues.
• Track CAPA progress and ensure timely closure in accordance with regulatory timelines.

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.
• Work with cross-functional teams to implement appropriate resolutions and preventive measures.

Regulatory Compliance & Documentation

• Ensure compliance with applicable regulations (e.g., FDA 21 CFR Part 820, ISO 13485) and industry best practices.
• Maintain accurate and complete records of quality activities, including CAPA reports, deviation logs, change control documentation, and batch release records.
• Support internal and external audits by providing required documentation and addressing audit findings.

Continuous Improvement

• 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.

Qualifications:

Education & Experience

• Bachelor's degree in Life Sciences, Engineering, or a related field (or equivalent experience).
• 2 years of experience in Quality Assurance within the medical device or sterilization industry (electron beam sterilization experience preferred).

Technical Skills

• Strong 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.

Soft Skills

• 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

• Experience working in electron beam sterilization or other terminal sterilization methods (e.g., ethylene oxide or gamma radiation).
• Proficiency in using electronic Quality Management Systems (eQMS).
• Certification in Quality Management Systems (e.g., CQE or CQA) is an advantage.

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Monday to Friday

Work Location: In person