Quality Assurance Specialist

hace 1 mes


Caimito, Puerto Rico Tek Support A tiempo completo

We are seeking an experienced Quality Assurance Specialist to join our team in Alameda, CA. The ideal candidate will play a key role in ensuring product quality and compliance with regulatory requirements in the medical device industry.
Responsibilities: Ensure compliance with FDA, ISO 13485, and other applicable regulations and standards throughout the product lifecycle.Conduct quality reviews and audits of processes, systems, and documentation to ensure adherence to quality standards and procedures.Support the development and implementation of quality assurance procedures and work instructions for manufacturing, testing, and inspection.Review and approve design history files, validation protocols, test plans, and reports to ensure product quality and compliance.Investigate and resolve non-conformances, CAPAs, and deviations, ensuring timely implementation of corrective and preventive actions.Participate in risk management activities, including the development and review of risk assessments, FMEAs, and control plans.Collaborate with cross-functional teams to identify and implement continuous improvement initiatives that enhance product quality and process efficiency.Prepare and present quality metrics, trends, and reports to management and stakeholders to support data-driven decision-making.Provide quality oversight during product transfers, process changes, and new product introductions.Support internal and external audits, representing the Quality Assurance team in audits conducted by regulatory agencies and notified bodies. Qualifications: Bachelor's degree in Engineering, Life Sciences, or a related field.3+ years of experience in quality assurance in the medical device industry.Strong knowledge of FDA, ISO 13485, and other regulatory standards.Experience with CAPA management, risk assessments, and validation activities.Excellent analytical and problem-solving skills.Strong communication and teamwork abilities.



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