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 implementation of QMS that is compliant with FDA 21 CFR Part 820 regulation.
Key Responsibilities:
Responsible for managing or governing all QMS-related processes per ISO 13485 standard e.g., CAPA, Nonconformance, Changes, Complaints handling, Recalls, Data analysis, Risk management.
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.
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.
Maintaining design control activities by ISO13485.
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Working closely with the Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Reports directly to the VP of Regulatory Affairs & QA
Requirements: Bachelors degree in Engineering or scientific discipline- required.
2+ years experience managing a team (with at least 3 members)
4-6 years of experience in quality assurance, in Medical devices.
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.
This position is open to all candidates.
