The Site Quality Engineer at the Medical Device Manufacturing Site in Chennai/ Bangalore, India, is responsible for establishing, maintaining, and improving the Quality Management System (QMS) at the site. The role will serve as the Single Point of Contact (SPOC) from the Quality function 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.
The personnel would own the Quality responsibilities applicable at the manufacturing site and would be Single-Point-of-Contact from QA Function for all site related Quality documentation.
Duties and Responsibilities
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 analyse 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.
Qualifications
Bachelor's degree in science or engineering.
Min. 2 years of experience in Quality Assurance or Quality Control or equivalent. Experience in Regulatory Affairs is preferred.
Experience in Medical Device domain is preferred.
Experience working in Multi-national company is preferred.
Demonstrates profound knowledge and expertise in QMS as per ISO 13485 and Indian Medical Device regulations.
Experience of handling/ leading Regulatory Authority or Notified Body Inspections/ Audits.
Strong learning ability, team player.
Excellent communication and interpersonal skills, with proficiency in both spoken and written English
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