QARA Executive at Andheri

1 week ago

Mumbai, India Illusion Dental Laboratory Full time

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

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