Sanjeev Kumar B Email & Phone Number

Banglore

• Quality leadership position supporting the plant quality manager in ensuring products are manufactured to specification and within compliance to relevant regulation and standards.• Responsible for process validation (IQ, OQ & PQ). Ensuring revalidation of process.• Preparing/Reviewing the validation protocols and reports. • Sterilizer validation (EO) and operation of HVAC validation. Ensuring revalidation of sterilizer.• Responsible for calibration of all measuring & process… Show more • Quality leadership position supporting the plant quality manager in ensuring products are manufactured to specification and within compliance to relevant regulation and standards.• Responsible for process validation (IQ, OQ & PQ). Ensuring revalidation of process.• Preparing/Reviewing the validation protocols and reports. • Sterilizer validation (EO) and operation of HVAC validation. Ensuring revalidation of sterilizer.• Responsible for calibration of all measuring & process equipment.• Working with operating staff to establish SOP, standards and systems.• Responsible for on time testing of incoming raw material, in-process material, assembled components, and finished product. • Ensuring Change Control process from initiation to end. • Ensuring of product quality plan, control plan, process FMEA.• Process improvement through applying various problem-solving tools (Brain storming, why-why analysis, 6M, 3C).• Responsible for implementation of Quality Management System as per ISO 13485. • Develop risk management plan, risk assessment and risk management report as per ISO 14971.• Prepare Medical Device File/Device Master File for each and every medical device product.• Investigates and analyses problems, recommends solutions and ensures corrections are made and personnel trained.• Monitor production conformance with QA standards and procedures.• Review customer specifications and requirements and develop internal QC specifications.• Analyse customer returns and complaints; work with production team on quality issues relating to inspection function. Develop quality reports for customers. Provide guidance in developing corrective actions to eliminate defects.• Responsible for customer complaint Analysis, trending and adequate & timely redressed.• Quality check of products label & ensure labels is complying to the regulatory guidelines. Show less

Hyderabad, Telangana, India

• Quality leadership position supporting the plant quality manager in ensuring products are manufactured to specification and within compliance to relevant regulation and standards.• Responsible for process validation (IQ, OQ & PQ). Ensuring revalidation of process.• Preparing/Reviewing the validation protocols and reports. • Sterilizer validation (EO) and operation of HVAC validation. Ensuring revalidation of sterilizer.• Responsible for calibration of all measuring & process… Show more • Quality leadership position supporting the plant quality manager in ensuring products are manufactured to specification and within compliance to relevant regulation and standards.• Responsible for process validation (IQ, OQ & PQ). Ensuring revalidation of process.• Preparing/Reviewing the validation protocols and reports. • Sterilizer validation (EO) and operation of HVAC validation. Ensuring revalidation of sterilizer.• Responsible for calibration of all measuring & process equipment.• Working with operating staff to establish SOP, standards and systems.• Responsible for on time testing of incoming raw material, in-process material, assembled components, and finished product. • Ensuring Change Control process from initiation to end. • Ensuring of product quality plan, control plan, process FMEA.• Process improvement through applying various problem-solving tools (Brain storming, why-why analysis, 6M, 3C).• Responsible for implementation of Quality Management System as per ISO 13485. • Develop risk management plan, risk assessment and risk management report as per ISO 14971.• Prepare Medical Device File/Device Master File for each and every medical device product.• Investigates and analyses problems, recommends solutions and ensures corrections are made and personnel trained.• Monitor production conformance with QA standards and procedures.• Review customer specifications and requirements and develop internal QC specifications.• Analyse customer returns and complaints; work with production team on quality issues relating to inspection function. Develop quality reports for customers. Provide guidance in developing corrective actions to eliminate defects.• Responsible for customer complaint Analysis, trending and adequate & timely redressed.• Quality check of products label & ensure labels is complying to the regulatory guidelines. Show less

Bangalore Urban, Karnataka, India

To prepare FAIR for new products, mold, fixture & inserts as per requirement. To prepare process design & protocols for process validation, Equipment & MSA. To prepare SOP, work instructions, control plan and Flow charts etc. Participate in FMEA & Risk Management. Participate in internal audit as auditor. Handling of change control & deviation. Coordinate with Customer during Customer Audit and to follow up to close the NC, CAPA implementation and monitor the… Show more To prepare FAIR for new products, mold, fixture & inserts as per requirement. To prepare process design & protocols for process validation, Equipment & MSA. To prepare SOP, work instructions, control plan and Flow charts etc. Participate in FMEA & Risk Management. Participate in internal audit as auditor. Handling of change control & deviation. Coordinate with Customer during Customer Audit and to follow up to close the NC, CAPA implementation and monitor the effectiveness. To perform SPC, process capability study. Root Cause identified by using 7 QC Tools Make quality judgments on vendor components as per drawing. Develop incoming inspection requirements for vendor components. Communicate quality concerns to internal issue and get corrective action from respective department. Use quality tools techniques to determine quality problems. Involving in process optimization and stabilization as and when necessary. Meeting of Quality Objective. Show less