QA MANGER

Responsibilities

• Lead all R&D projects from the design QA side through the design phases.

• Ensure compliance with DHR and DMR requirements.

• Develop and manage risk mitigation strategies for the project together with R&D.

• Support regulatory submissions.

• Plan, establish, and maintain the effectiveness of company quality to meet regulatory expectations.

• Ensure the company’s product quality and reliability to meet or exceed customer expectations.

• Ensure Quality Compliance with regulatory agencies and all applicable standards worldwide.

• Provide effective leadership support, training, and guidance to all company personnel in support of the quality system.

• Lead MRB, CAPA, and ECO committees.

• Approval, audit, and control subcontractor performance.

• Establish and control the traceability system of company products (DMR).

• Approve the release of finished products.

Qualifications

• B.A. or B.S. degree in a technical discipline, such as Engineering or Science.

• At least 5+ years of experience in the medical device industry.

• Multidisciplinary experience in medical devices (mechanics, hardware, software).

• Strong knowledge of design control regulations and standards (e.g., FDA, ISO 13485).

• Experienced with IEC 60601 and IEC 62304.

• Demonstrated expertise in leading design control activities, including risk management, verification/validation, and documentation.

• Excellent understanding of quality management systems and their application in the design process.

• Experience with internal and external audits related to design control and quality assurance.

• Strong analytical and problem-solving skills, with keen attention to detail.

• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.

• Proficient use of standard MS Office applications.

• Fluent in English (oral and written).