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Quality Assurance Specialist

1 month ago

Chennai, Tamil Nadu, India Advanced Sterilization Products Full time
About the Role

We are seeking a Quality Assurance Specialist to join our team at Advanced Sterilization Products in Chennai/Bangalore, India. The successful candidate will be responsible for establishing and maintaining our Quality Management System (QMS) at the site.

Key Responsibilities
  • Quality Management System (QMS) Implementation and Maintenance:
    • Oversee the implementation and continuous improvement of the QMS at the site, including training, internal audits, nonconformance handling, CAPA, records management, field actions, supplier quality management, and post-market surveillance.
  • Documentation Management:
    • Develop and maintain procedures/work instructions to ensure compliance with all applicable laws and internal policies.
  • Compliance Monitoring and Metrics:
    • Track, maintain, and analyze quality compliance metrics to identify gaps and recommend corrective actions to ensure ongoing compliance and continuous improvement of the QMS at the site.
  • Inspection and Quality Control:
    • Conduct incoming raw material inspections, in-process quality control tests, and release testing of finished products, generating all applicable records per procedures.
  • Supplier Management:
    • Evaluate and manage suppliers to ensure adherence to our quality standards and regulatory requirements.
  • Audit and Inspection Readiness:
    • Lead or support audits and inspections at the site, ensuring the site remains audit-ready and compliant with regulatory and internal standards.
  • Cross-functional Coordination:
    • Collaborate with local and global teams to address quality assessments and ensure timely execution of corrective actions.
  • Change Management:
    • Review, approve, and implement product or process changes, ensuring that changes are documented and closed in the Change Management System.
  • CAPA and Post-audit Follow-up:
    • Drive corrective and preventive action processes and follow up on post-audit activities until closure.
Requirements
  • Education: Bachelor's degree in science or engineering.
  • Experience: Minimum 2 years of experience in Quality Assurance or Quality Control or equivalent, preferably in the Medical Device domain.
  • Skills: Demonstrated knowledge and expertise in QMS as per ISO 13485 and Indian Medical Device regulations, excellent communication and interpersonal skills, proficiency in spoken and written English.
Compensation

The estimated salary for this position is ₹850,000 - ₹1,200,000 per annum, depending on qualifications and experience.