We’re looking for Quality Assurance and Design Control Manager to join our team to support our multidisciplinary and innovative R&D processes and ensure they meet quality standards.
Responsibilities:Provide professional QA and Regulatory guidance throughout the entire product lifecycle: from the early feasibility through planning, the development until post-marketing stages. Guidance in accordance with the Design and Development requirements per ISO13485 and Product Realization.
Maintaining design control activities in accordance to ISO13485
Ensuring validation processes are performed and documented.
Provide support for risk analysis processes and technical file maintenance.
Provide guidance for change control activities and QA change control assessments per the company’s internal procedure.
Assuring production line compliance and working closely with subcontractors.
Ensuring compliance with in-house procedures through ongoing, periodic audits or inspections.
Working closely with Syqe Medical Engineering team and R&D team
Making the quality world accessible to the Engineering and R&D team
Position Requirements
Bachelor’s degree in Engineering or scientific discipline- required.
4-6 years of experience in quality assurance, in the Medical Device.
Excellent familiarity and previous experience with Medical devices design control process per ISO13485.
Experience with internal auditing-Advantage.
Familiar with standards and methodologies (e.g., ISO13485, ISO14971, IEC62304)- Advantage.
