Key Responsibilities:
Develop, implement, and maintain CAPA processes in compliance with FDA 21 CFR Part 820 and ISO 13485 standards.
Conduct thorough investigations to identify root causes of nonconformities and quality issues.
Collaborate with cross-functional teams to develop and implement effective corrective and preventive actions.
Monitor and analyze quality data to identify trends and areas for improvement.
Prepare and present CAPA reports to management and regulatory bodies.
Provide training and guidance to staff on CAPA processes and best practices.
Ensure timely closure of CAPAs and verify the effectiveness of implemented actions.
Support internal and external audits related to CAPA processes.
Process non-conforming products, execute identified corrective actions, update procedures, and support production in a team setting.
Qualifications:
Bachelor's degree in Engineering, Life Sciences, or a related field (preferred but not required).
Minimum of 2 years of experience in quality management within the medical device industry.
In-depth knowledge of FDA regulations (21 CFR Part 820) and ISO 13485 standards.
Proven experience in managing CAPA processes and conducting root cause analysis.
Strong analytical and problem-solving skills.
Excellent communication and interpersonal skills.
Ability to work independently and as part of a team.
Certification in Quality Management (e.g., ASQ CQE, CQA) is a plus.
Familiarity with Microsoft Office Suite.
Preferred Skills:
Experience with quality management software and tools.
Familiarity with risk management principles and practices.
Project management experience.
Ability to prioritize work and execute projects/actions with minimal guidance.
Quick learner with an understanding of the medical device field.
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