Senior Quality Assurance Compliance Specialist
- הרצליה
- משרה קבועה
- משרה מלאה
- Provide ongoing support for the company's quality management activities, including SDLC, PMS, product investigation, operations, training management, supplier management, and document control
- Maintain the company's quality management system (QMS)
- Evaluate and address quality assessment related to customer complaints
- Prepare and maintain technical documentation in compliance with standards such as ISO 13485, 21 CFR 820, and IVDR
- Collaborate with cross-functional teams, including R&D, product development, and technical support on quality-related activities
- Perform privacy-related tasks, such as evaluating suppliers for privacy compliance and reviewing data processing agreements (DPAs)
- Analyze post-market surveillance data to support company initiatives
- Prepare teams for internal and external audits
- Bachelor's degree in industrial engineering, biotechnology engineering, life science/exact science, or law
- At least 5 years of experience working with the QMS of a medical device company, including development, implementation, or compliance with standards such as ISO 13485 and FDA regulations
- Understanding of QA processes and methodologies (ISO 13485:2016, 21 CFR 820 or similar)
- Understanding of privacy requirements such as HIPAA, GDPR and ISO27799
- Ability to collaborate effectively with cross-functional teams to achieve quality objectives
- A motivated, collaborative, and proactive approach to work
- Team orientation
- Excellent communication skills (both written and verbal)
- Strong attention to detail
- Ability to lead and implement processes
- English proficiency
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