Medical Device _ QA Manager

Client Description

• Renowned medical device company, recognized for its innovation and commitment to providing high-quality healthcare products. The company maintains a strong market presence and places a high value on regulatory compliance, product safety, and operational efficiency.

• Establishing standards, policies, and procedures for testing processes and procedures
• Managing the testing process by planning, scheduling, organizing, and coordinating efforts with other departments and personnel
• Reviewing results of tests to ensure that they meet established standards or making adjustments to improve results
• Working with software engineers to develop test plans and scripts to automate testing
• Performing quality assurance audits to ensure that the organization meets industry standards for best practices
• Conducting training sessions for new team members to ensure that they understand their roles in the testing process

• At least 5 years of experience in quality assurance within the medical device or healthcare industry.
• Proven experience in regulatory compliance, particularly in the areas of GMP, GDP, and QMS.
• Solid understanding of medical device regulations, including local health authority requirements and global standards.

• Bachelor’s degree or higher in a related field such as Life Sciences, Engineering, or Quality Assurance.
• Additional certifications or training related to medical device regulation or quality management systems are a plus.