Quality Assurance Specialist

3 days ago

Mumbai India Illusion Dental Laboratory Full time

Job Description Job Description Job Title: Quality Assurance Executive No of Vacancy: 1 Job Location: Mira Road/Wada/Boisar/ Kerala Years of Experience: 1-4 years Working Days: Monday to Saturday Job Purpose: We are looking for a detail-oriented and committed Quality Assurance Executive to support and enhance our Quality Management System (QMS) in compliance with ISO 13485, 21 CFR Part 820, and other applicable regulatory standards. This role involves document control, audit support, CAPA management, and coordination with internal teams to ensure high-quality standards across operations. Educational Qualifications: Bachelor's and/or Master's degree in Pharmaceutical Sciences, Engineering, Biotechnology, Microbiology, or any relevant Life Sciences discipline. Specialization in Regulatory Affairs or Quality Assurance is preferred. Key Skills & Competencies: Strong understanding of ISO 13485 and 21 CFR 820 requirements Knowledge of MDSAP standards is a plus Excellent documentation practices and scientific writing skills Familiarity with internal audit requirements; Internal Auditor certification preferred Good presentation and communication skills Ability to collaborate with cross-functional teams Professional Experience: 1 to 4 years of hands-on experience in Quality Assurance within a regulated industry such as Medical Devices, Pharmaceuticals, or Life Sciences Proven experience in: Preparing and maintaining SOPs, Work Instructions, and other QMS documentation Managing document control and maintaining regulatory records Participating in internal and external audits Supporting CAPA, complaint handling, and feedback mechanisms Assisting in supplier evaluation, communication, and audit coordination Key Responsibilities: Develop and maintain Standard Operating Procedures (SOPs) and Work Instructions in alignment with regulatory standards Ensure proper document and record control in accordance with ISO 13485 and other applicable quality standards Participate in quality audits (internal and external) and assist in audit readiness activities Identify and implement corrective and preventive actions to address non-conformities Conduct root cause analysis as part of CAPA and complaint handling processes Present periodic reports on QMS performance and effectiveness to the Quality Head/Management Collaborate with internal departments to improve compliance and support continuous quality improvement Assist in setting up and improving feedback and complaint handling systems Soft Skills & Attributes: Strong English proficiency verbal and written Go-getter attitude and self-motivated Willingness to learn, lead, and take initiative Strong sense of accountability and integrity Excellent team collaboration and interpersonal skills Ability to work effectively under guidance as well as independently Monday to Saturday working Company Website: https://www.illusionaligners.com/

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