Education & experience required: Can be Graduate or Post Graduate in Engineering/Pharmacy/Life Sciences with minimum of 2 years of working experience in the Quality Control department of medical devices and is aware of ISO 13485 & QMS requirements.
Roles & responsibility
- QC head/QC Manager is responsible for to define inspection activities for incoming, in process & finished goods.
- QC head/QC Manager to review the implementation & efficiency of quality & inspection systems.
- QC head/QC Manager to Investigate and analyze defects or non-conformities, identifying root causes and implementing corrective actions.
- QC head/QC Manager to establish and manage sampling plans for incoming materials, in-process production, and finished goods.
- QC head/QC Manager to manage and calibrate measurement and testing equipment to ensure accuracy and reliability.
- QC head/QC Manager use statistical tools to analyze data and trends, ensuring process stability and capability.
- QC head/QC Manager ensures that products meet quality standards before release to customers, following established protocols.
- QC head/QC Manager develop and manage procedures for handling non-conforming products, including quarantine, disposition, and corrective actions.
- QC head/QC Manager collaborate with suppliers to establish and maintain quality standards for incoming materials.
- Provide training to quality control staff on inspection techniques, standards, and procedures.
- Define inspection activities for incoming, in process & finished goods
- Supervise workers engaged in inspection and testing activities to high productivity.
Authorities
- Authorized for safe disposition of Non-Conforming Product.
- Authorized for product Re-call and Return goods material.
- Authorized for implementation of Deviation Approval Request.
- Authorized for taking corrective and preventive action.
- Authorized to sign the testing reports and CoA.
Work Location - Vasai Mumbai, Maharashtra, India