Medical Device Quality Assurance Specialist

If you are a highly motivated and detail-oriented individual with a passion for ensuring the quality and safety of medical devices, we encourage you to apply for this exciting opportunity.

Job Title: Medical Device Quality Assurance Specialist

Position Overview: We are seeking a highly skilled and experienced Medical Device Quality Assurance Specialist to join our team. In this role, you will be responsible for ensuring the quality and safety of our medical devices through compliance with regulatory standards and internal quality assurance processes. As a key member of our quality assurance team, you will play a crucial role in maintaining our reputation for delivering high-quality, reliable medical devices to our customers.

Key Responsibilities:

• Conduct quality assurance activities for all stages of the medical device lifecycle, from design and development to manufacturing and distribution
• Develop and implement quality assurance processes and procedures in compliance with relevant regulatory standards, including FDA, ISO, and other applicable regulations
• Review and approve design and manufacturing documentation, such as design specifications, test protocols, and process validation reports
• Conduct internal audits to assess compliance with quality system requirements and identify areas for improvement
• Collaborate with cross-functional teams, including R&D, manufacturing, and regulatory affairs, to ensure quality standards are met throughout the product development and manufacturing process
• Lead investigations and root cause analyses for any quality issues, and implement corrective and preventive actions to prevent recurrence
• Monitor and analyze quality metrics to identify trends and areas for improvement, and provide recommendations for process and product enhancements
• Support external audits and regulatory inspections, and assist with the preparation of responses to any findings or observations
• Stay up-to-date on industry trends, regulatory changes, and best practices in medical device quality assurance, and make recommendations for process improvements and compliance enhancements

Qualifications:

• Bachelor's degree in Engineering, Science, or a related field
• Minimum of 3-5 years of experience in quality assurance within the medical device industry
• In-depth knowledge of FDA regulations, ISO standards, and other applicable quality system requirements
• Experience with design controls, risk management, and process validation
• Strong analytical and problem-solving skills, with the ability to lead investigations and implement effective corrective and preventive actions
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
• Attention to detail and a passion for maintaining high quality standards
• Ability to work independently and manage multiple priorities in a fast-paced environment
• Certified Quality Auditor (CQA) or other relevant certifications are a plus

Join our dynamic team and make a meaningful impact on the lives of patients around the world.