Responsibilities

• Implement, maintain and manage a companywide QMS based on ISO 13485.
• Responsible for all QA/RA activities including: CAPA, MRB, ECO, training and supplier management.
• Perform internal and supplier audit and prepare the company for regulatory audits.
• Create Quality Metrics and prepare for Management Review.
• Develop companywide training and documentation materials to enable the seamless knowledge transfer of project and manufacturing processes.
• Establish and maintain design control processes including risk management according to ISO 14971.
• Responsible for contact with regulatory authorities including regulatory submission and compliance.
• Provide quality guidance and leadership to other team members.

Requirements

• At least 4 years of experience maintaining quality systems in the medical device industry.
• Experience in writing and maintaining DHF related documents.
• Experience in writing and maintaining design control and risk management processes.
• Experience in writing and implementing Quality Procedures.
• Experience in quality related processes such as: CAPAs, MRB/NCR, in process tests and final release.
• Knowledge in industry related standards and their interpretation.
• Experience in writing and submitting regulatory documents.
• Participation in regulatory audits.
• Familiarity with 62304.
• Fast learner and an independent worker.
• Languages: strong command of English (reading, writing and speaking).

General details

• Full time position, work from the Hi-Tech Village in Givat-Ram.

For more information and to submit your CV: careers@brainqtech.com

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