Quality Manager
Job Location:
Monthly Salary:
Posted on:
2 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Final Inspection:
- Visual and functional checks ensure that products align with design and manufacturing standards by Inspecting and testing products to ensure they meet specified standards before delivery.
- Authority related to final inspection approval and shipment readiness decisions.
- Accountability for final product compliance prior to dispatch
- Beforehand conducting inspections at various production stages to identify and address defects.
- Final inspection governance.
- Device History Record (DHR) review and batch release readiness.
- Outgoing Quality Inspection (OQI).
- Verification of manufacturing documentation completeness prior to shipment.
- Final compliance assurance aligned with regulatory and customer specifications.
- This will maintain clear separation between IQC IPQA and FQC responsibilities.
Product Release Authority
- Review and approval of batch manufacturing records and Device History Records.
- Verification of testing data and traceability prior to shipment.
- Escalation authority where compliance concerns exist
Responsible for Outgoing Quality Inspection (OQI):
- To do final comprehensive review before the shipment. It includes validating manufacturer test data and conducting independent evaluations.
Responsible for conducting Corrective and preventive action
- Supporting CAPA investigations related to final inspection failures or outgoing quality deviations
- Reviewing implementation effectiveness where shipment readiness is impacted
Stakeholder & Customer Exposure
- Customers during shipment-related quality queries.
- Auditors and regulatory authorities during inspections.
- Cross-functional manufacturing and supply chain teams
Customer Delight and Reliability ensuring robust final quality control to reduce costly errors minimize product recalls and ensure consistent product quality to maintain customer satisfaction and reliability.
3. Audit & Compliance Management
- Maintain records and documents for internal/ external audits (ISO regulatory authorities Customer Audits)
- Preparing inspection reports with clarity legibility and accuracy.
- Review and release Batch manufacturing records (Device History Record - DHR)
- Ensure timely closure of audit non-conformities (NCs)
- Ensure full compliance with laws regulations SOPs and industry guidelines
- Maintenance of inspection and batch documentation for regulatory and customer audits.
- Participation and support during external audits related to product release activities.
4. Cross-Functional Leadership & Coordination
- Coordinate with Production QC R&D Supply Chain and Materials departments
- Ensure manufacturing and FQC processes comply with ISO and GMP
- Oversee supplier qualification approval monitoring and re-evaluation
- Prepare and present MIS reports for FQC
- Lead mentor and develop FQC team and processes
