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.
