Job Detail

Job Description

• Understand customer needs and requirements to develop effective quality control processes

• Devise and review specifications for products or processes

• Lead QMS system in the organization and ensure compliance of the system

• Create, review, revise and maintain quality documentation such as Quality manuals, Quality procedures, SOP, formats etc of all the inter departments

• Lead and conduct Improvement activities to enhance the Quality management systems

• Interfacing production, technical and other interrelated departments to ensure products, processes comply with all relevant requirements of QMS

• Preparing audit plans, conduct audits, creating audit findings reports, including closing the audit findings through CAPA by proper corrective and preventive actions.

• Conduct Management review meetings along with the top management & all HOD’s

• Analyzing failures, corrective actions, and preventive actions to respond to the customer complaints if any

• Coordinate with production and technical team on executing Risk assessments & its closure

• Direct changes in process or product to ensure timely execution of Change managements

• Management of IQ, OQ, PQ validations and management of its records

• Assists all inter departments in standardization and simplification of documentation, records management and better document control to have smooth work flow

• Prepare plan and execute trainings related to QMS system in the organization.

• Set requirements for raw material or intermediate products for suppliers and monitor their compliance

• Oversee all product development procedures to identify deviations from quality standards

• Inspect final output and compare properties to requirements

• Keep accurate documentation and perform statistical analysis

• Solicit feedback from customers to assess whether their requirements are met

• Submit detailed reports to appropriate executives

• Be on the lookout for opportunities for improvement and develop new efficient procedures

• Operated as Specialist in Quality assurance and quality control in a high volume manufacturing industry.

• Total 10 years of experience of which 7-8 years of relevant experience in Quality Function for a manufacturing company

• Quality Management Systems & Quality Control; regulatory compliance, Audits as per ISO 13485; team management; Stakeholder management

• Industrial Experience of One or more of the following: Medical device or Pharmaceuticals

• Bachelor’s degree in Engineering (Mechanical / Industrial / Production / Chemical)

Skills Required

• Quality Assurance
• Quality Control
• Quality Documentation
• Quality Manuals
• CAPA
• Lens
• Audits
• Review meetings
• Risk Assesment
• Change Management
• Regulatory Compliance