Medical Devices Quality Assurance Specialist

At our company, we are committed to providing our customers with high-quality and safe medical devices. As a Medical Devices Quality Assurance Specialist, you will have the opportunity to make a significant impact on the quality of our products and the satisfaction of our customers.

Position: Medical Devices Quality Assurance Specialist

Overview: We are seeking a highly skilled and detail-oriented Medical Devices Quality Assurance Specialist to join our dynamic team. This individual will play a critical role in ensuring the safety, effectiveness, and quality of our medical devices. The ideal candidate will have a strong background in quality assurance, regulatory compliance, and a deep understanding of medical device regulations and standards.

Key Responsibilities:

• Develop and maintain quality management systems to comply with applicable regulations and standards such as ISO 13485, FDA QSR, and MDR
• Conduct internal audits and assist in external audits to ensure compliance with regulatory requirements
• Perform risk assessments and implement risk management strategies for new and existing medical devices
• Review and approve design control documents such as design inputs, design outputs, verification and validation protocols
• Collaborate with cross-functional teams to ensure that all quality requirements are met throughout the product lifecycle
• Investigate and resolve product quality issues, non-conformances, and customer complaints
• Develop and implement corrective and preventive actions to address quality issues and prevent recurrence
• Monitor and analyze quality data to identify trends and areas for improvement
• Provide guidance and support to other departments to ensure quality requirements are met
• Keep abreast of changes in regulations and standards related to medical devices and advise on necessary updates to quality management systems

Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related field
• Minimum of 3 years of experience in medical device quality assurance, preferably in a regulated environment
• Strong knowledge of medical device regulations and standards such as ISO 13485, FDA QSR, and MDR
• Experience in conducting internal audits and participating in external audits
• Excellent analytical and problem-solving skills
• Strong attention to detail and ability to prioritize tasks in a fast-paced environment
• Excellent written and verbal communication skills
• Ability to work collaboratively and effectively in a cross-functional team
• Familiarity with statistical tools and methods used in quality engineering is a plus

If you are passionate about quality and have the required skills and experience, we invite you to apply for this exciting role and join our team!.