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| Job Location | Bangalore |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Automobile / Auto Ancillaries |
| Functional Area | Sales / BD |
| EmploymentType | Full-time |
Roles and ResponsibilitiesWe are looking for a female candidate for this position. Candidate needs to be aware of ISO 9001, ISO 13485. Ideal candidate would be from a medical component/ pharma/ bio-pharma company. If not available then you can look for plastic/ polymer companies. Candidate would be verifying batch records, processes and SOP followed. Job Title Engineer Quality (LS) Grade M11 Department / SOA Quality Business Reports to Manager - Quality Experience 3-5 Years Qualification B.Tech Mechanical Gender : Female Job Purpose: Organisation Perspective: To ensure organization, customer and product requirements are met and continually improve the quality systems. Customer perspective: To understand the customer requirements related to product, quality system and ensure the implementation of the requirements in the organization. Position Summary: Implementation and oversight of a Quality Management System Customermanagement Key Responsibilities / Accountability: Implementation and oversight of a Quality Management System that operates in compliance with corporate quality policies and procedures, and relevant regulatory requirements and industry guidance, including: - Implementation of document control and review/approval of controlled documents - Implementation of change management and review of all change controls - Implementation of supplier quality management and performance of supplier audits as appropriate - Complaint management including robust root cause analysis and CAPA - Implementation of an effective Internal Audit Program- Ensure adequate Training Program is in place - Implementation of applicable Validation Master Plans including equipment, process, product, sterilization and test methods - Testing and approval of QC testing - Maintenance of clean room Quality Engineer practices including qualification, monitoring and behavior - Implementation of Quality Risk Management in relevant aspects of the QMS Customer Management, including: - Facilitate/host customer audits - Ensure robust and effective corrective action to customer audit observations. - Review/approve Quality Agreements with customers - Partner in the resolution of Quality Issues and requests for information by initiating effective interdepartmental communication. - Manage ISO 9001 Certification & Maintenance of certification Functional Skills : 1. Ability to understand customer requirements 2. Knowledge on measurement & testing methods. 3. Root cause analysis & quality tools 4. Knowledge on ISO9001:2008 standard and auditing skills. 5. Ability to host and facilitate customer audits. 6. Ability to train and deliver on customer and quality system requirements. 7. Knowledge on practices followed in pharma and life science industry 8. Able to plan and ensure calibration of instruments. ,
Keyskills :
internal auditrisk managementisovalidation master plansroot cause analysisiso 9001batch recordscustomer auditsqualityroot causequality controlquality management systemsupplier qualityinspectionquality toolssupplier auditssupplier quality m