Company Overview

Illusion Dental Laboratory is committed to providing the highest quality dental restorations with exceptional customer service. We specialize in using top-tier restorative systems like Bruxzir and Zirconia. Based in Mumbai, we focus on building strong relationships through effective communication and feedback.

Job Overview

We are seeking a Junior QARA Executive to join our full-time team in Mumbai. The ideal candidate will have 1 to 3 years of relevant work experience in regulatory affairs and quality assurance within the medical device industry.

Qualifications and Skills

• Regulatory compliance expertise, including understanding of required regulations and standards like ISO 13485 and EU MDR (Mandatory skill)
• Hands-on experience with FDA regulations to ensure that all products meet required standards
• Strong ability in handling CAPA management to address and resolve quality issues effectively
• Sound knowledge of risk management practices to maintain product quality and compliance
• Quality auditing experience to ensure internal processes align with industry standards
• Must be familiar with medical device regulations to oversee compliance with industry requirements
• Proficiency in ISO 13485 for managing and maintaining quality management systems (Mandatory skill)
• Deep knowledge of EU MDR to ensure alignment with European standards (Mandatory skill)

Roles and Responsibilities

• Ensure compliance with regulatory standards and quality control procedures in dental restoration production
• Conduct and manage audits to maintain ISO 13485 certification and overall product quality
• Collaborate with cross-functional teams to implement and improve CAPA processes
• Monitor and report product quality metrics to identify potential risks and areas of improvement
• Support the development and maintenance of regulatory strategies to meet global compliance requirements
• Keep up-to-date with industry trends and changes in regulations to adapt policies accordingly
• Provide guidance on regulatory documentation and submissions, ensuring accuracy and completeness
• Assist in training team members on compliance and quality assurance best practices