Quality Assurance Manager

Syqe Medical is a dynamic company specializing in designing, developing, and manufacturing innovative medical devices for inhaling plant substances.

We are seeking a highly skilled QA and Design Control Manager with proven experience in the medical devices industry to join our team and contribute to the effective maintenance of our (MDR) ISO13485 certified Quality Management System and move us ahead with the implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.

Responsibilities

• Responsible for managing or governing all QMS related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Management Reviews, Changes, Complaints handling, Recalls, Data analysis, Risk management.
• Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, and development until the post-marketing stages.
• Guidance by the Design and Development requirements per ISO13485 and Product Realization.
• Assuring production line compliance and working closely with the QA at the contracted manufacturer.
• Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
• Maintaining design control activities by ISO13485.
• Ensuring validation processes are performed and documented.
• Provide support for risk analysis processes and participation in risk management meetings.
• Working closely with the Syqe Medical Engineering team (NPI, Validations) and with the R&D team
• Reports directly to the VP of Regulatory Affairs & QA
  
  

• A bachelor’s degree in engineering or a scientific discipline is required.
• 2+ years experience managing a team (with at least three members)
• 4-6 years of experience in quality assurance and medical devices.
• Active participation and lead at Regulatory Audits (ISO13485, MDR).
• Excellent familiarity and previous experience with Medical devices design control process per ISO13485 and 21 CFR Part 820.30
• Previous experience with FDA 21 CFR Part 820 Quality System Regulation.
• Experience with internal auditing-Advantage.
• Familiar with standards and methodologies (e.g., ISO13485, ISO14971, IEC62304)- Advantage.
• Possess excellent writing skills in English.
• Exhibit exceptional teamwork abilities and effective communication skills in both Hebrew and English.