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Site Quality Assurance Expert
2 months ago
The Advanced Sterilization Products (ASP) Medical Device Manufacturing Site in Chennai/Bangalore, India, seeks a highly skilled Site Quality Engineer to establish, maintain, and improve the Quality Management System (QMS) at the site.
As a key member of the Quality function, this role will serve as the Single Point of Contact (SPOC) for all site-related quality documentation, ensuring adherence to applicable regulatory standards, including ISO 13485 and ASP's global quality management system.
This position reports to the RAQA Manager – Greater India and requires close interaction with local teams, global counterparts, and external regulatory bodies to ensure compliance with country-specific regulations and ASP's internal policies.
Quality Responsibilities
- Responsible person: Serve as the responsible person (Technical Staff) for all QA-related deliverables at the site, ensuring compliance with standard operating procedures (SOPs).
- QMS Implementation & Maintenance: Oversee the implementation and continuous improvement of the Quality Management System at the site. Key areas include 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, ensuring documentation and records are up to date and accurately maintained.
- Compliance Monitoring & Metrics: Track, maintain, and analyze quality compliance metrics, identifying gaps and recommending corrective actions to ensure ongoing compliance and continuous improvement of the QMS at the site.
- Inspection & 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: Ensure supplier-related processes are adhered to and supplier documentation is properly maintained. Communicate with critical raw material suppliers and maintain relevant material-related data.
- Product Labelling Compliance: Ensure product labelling is in line with local regulatory requirements and internal guidelines.
- Audit & Inspection Readiness: Lead or support audits and inspections at the site, ensuring the site remains audit-ready and compliant with regulatory and internal standards. Collaborate with regulatory bodies as necessary.
- Cross-functional Coordination: Collaborate with local and global teams to address quality assessments, ensuring timely execution of corrective actions.
- Change Management: Lead the review, approval, and implementation of product or process changes, ensuring that changes are documented and closed in the Change Management System.
- CAPA & Post-audit Follow-up: Drive corrective and preventive action processes and follow up on post-audit activities until closure.
- Verification & Validation: Lead or support verification and validation activities and maintain relevant documentation.
- Regulatory Licensing & Certification: Maintain a database of regulatory licenses and QMS certifications, tracking their validity and supporting renewal processes as necessary.
- Support Business & Regulatory Needs: Provide quality support to the local and global teams for product distribution and service-related activities to ensure compliance with business and regulatory requirements.
Other Responsibilities
- Continuous Improvement: Collaborate on short-term and long-term strategies for improving systems and processes, ensuring alignment with business and regulatory requirements.
- Regulatory Monitoring: Monitor and interpret new and revised regulations and standards, ensuring communication of changes to relevant teams.
- Project Support: Lead or support projects, initiatives, and other assignments as directed by the RAQA Manager.
- Training Compliance: Maintain a training matrix for the site and ensure personnel are trained on required procedures before performing site-related activities.
