Medical Device Quality Assurance Specialist

We are looking for a highly motivated and passionate individual who is dedicated to ensuring the quality and safety of medical devices. If you have a strong background in quality assurance and a passion for the healthcare industry, we encourage you to apply for this exciting opportunity.

Position: Medical Device Quality Assurance Specialist

Job Description: We are seeking a highly skilled and detail-oriented Medical Device Quality Assurance Specialist to join our dynamic team. As a Medical Device Quality Assurance Specialist, you will be responsible for ensuring the safety, effectiveness, and quality of medical devices produced by our company. This role will require you to have a deep understanding of quality assurance principles and regulations in the medical device industry.

Key Responsibilities:

• Develop, implement, and maintain quality assurance processes for medical devices in compliance with FDA regulations and industry standards
• Conduct risk assessments and develop risk management plans for new and existing medical devices
• Perform thorough reviews of design and manufacturing processes to identify potential issues and provide recommendations for improvement
• Conduct inspections and audits of manufacturing facilities to ensure compliance with quality standards and regulations
• Create and maintain quality documentation including standard operating procedures, work instructions, and quality control plans
• Collaborate with cross-functional teams to develop and implement corrective and preventive actions to address quality issues
• Ensure all medical devices are properly tested and validated before release to the market
• Stay up-to-date with industry developments and changes in regulations to ensure compliance and make necessary adjustments to quality processes
• Participate in training programs to educate employees on quality assurance processes and procedures

Qualifications:

• Bachelor's degree in a related field such as biomedical engineering, quality assurance, or a related discipline
• Minimum of 3 years of experience in quality assurance within the medical device industry
• Strong knowledge of FDA regulations and industry standards such as ISO 13485 and 21 CFR Part 820
• Experience with risk management and quality control processes
• Excellent analytical and problem-solving skills
• Strong attention to detail and ability to work in a fast-paced, deadline-driven environment
• Excellent communication and interpersonal skills to effectively collaborate with cross-functional teams
• Proficient in using quality management software and Microsoft Office Suite

Join our team and make a difference in the lives of patients by ensuring the quality of our medical devices.