Medical Device Quality Assurance Specialist

At HealthTech Innovators, we value our employees and strive to create a positive and inclusive workplace. We offer competitive compensation and benefits, as well as opportunities for professional growth and development. Our team is made up of talented individuals who are passionate about making a difference in the medical device industry.

Position: Medical Device Quality Assurance Specialist

Location: Ghent, Belgium

Company Overview: HealthTech Innovators is a leading medical device company that specializes in the design, development, and manufacturing of innovative medical devices. Our mission is to improve patient outcomes and quality of life by delivering advanced medical solutions to healthcare providers and their patients. As a growing company, we are dedicated to maintaining the highest standards of quality and safety in our products.

Role Overview: We are seeking a highly skilled and detail-oriented Medical Device Quality Assurance Specialist to join our Quality Assurance team. In this role, you will play a critical role in ensuring that our medical devices meet all regulatory and quality standards. You will work closely with cross-functional teams to support the development, manufacturing, and distribution of our medical devices.

Key Responsibilities:

• Conduct thorough quality inspections of medical devices throughout the manufacturing process to ensure compliance with FDA regulations and company standards
• Perform root cause analysis and implement corrective actions for any quality issues that arise
• Develop and maintain quality assurance procedures and guidelines in accordance with FDA regulations and industry best practices
• Collaborate with cross-functional teams to review and approve design changes, process improvements, and new product development
• Review and approve documentation related to manufacturing processes, including validation protocols, test methods, and quality plans
• Lead and participate in internal and external audits to ensure compliance with quality standards and regulations
• Communicate quality issues and updates to relevant departments and management
• Stay up-to-date with industry trends and regulations and make recommendations for process improvements and quality initiatives

Qualifications:

• Bachelor's degree in a relevant field such as engineering, biology, or chemistry
• Minimum of 3 years of experience in quality assurance within the medical device industry
• Knowledge of FDA regulations and ISO standards for medical device manufacturing
• Strong analytical skills and attention to detail
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team in a fast-paced environment
• Experience with risk management and root cause analysis techniques
• Quality audit experience is preferred
• ASQ certification in quality assurance is a plus

Working at HealthTech Innovators: If you are looking for a dynamic and challenging role with a company that is making a real impact, then we encourage you to apply for the position of Medical Device Quality Assurance Specialist at HealthTech Innovators.