33 Job openings found

Production & Process Management Supervise day-to-day manufacturing of PTCA balloons as per defined SOPs. Monitor critical process parameters such as extrusion, balloon forming, pleating, folding, bonding, and assembly. Ensure production output meets planned schedules, quality standards, and yield targets. Identify and troubleshoot process deviations, implement corrective and preventive actions (CAPA). Quality & Compliance Ensure ...

Key Responsibilities- Monitor and ensure compliance with quality standards at every stage of production from raw material to finished goods- Implement and maintain documentation for QA processes, batch records, and product testing reports- Conduct in-process and final inspections of products like abdominal belts, LS belts, cervical collars, gauze swabs, etc- ...

Project Setup & Execution: Lead the project for setting up a filter manufacturing line (e.g., pleated filters, capsule filters, depth filters). Define layout and workflow for cleanroom and production areas as per ISO Class requirements. Identify, evaluate, and oversee installation of machinery (pleaters, welders, integrity testers, etc.). Coordinate with vendors, contractors, and internal stakeholders ...

Description : Regulatory Compliance: Stay updated on medical device regulations, standards, and guidelines (e.g., FDA, ISO, CE Marking). Ensure that products meet all regulatory requirements and maintain relevant documentation. Quality Assurance: Develop and implement quality assurance processes and procedures. Conduct internal audits and assessments to identify areas for improvement. Collaborate with production teams to establish quality control ...

DUTIES AND RESPONSIBILITIES: To coordinate import export activities. To planning and managing logistics, warehouse, transportation and customerservices. To directing, optimizing and coordinating full order cycle. To keep track of quality, quantity, stock levels, delivery times, transport costs andefficiency. To negotiate rates and contracts with transportation and logistics providers. To recommend ...

Position:           CNC Programmer Location:          Degam nearby Vapi Experience:      4 - 5 years Industries:        Plastic Responsibilities:         Develop, modify, and optimize CNC programs (e.g., using Mastercam, Siemens NX, or similar software) for milling, turning, and multi-axis machines. Read and interpret engineering drawings, ...

Position: RA & QA Associate Location: DelhiWorking Days: 5 Days | Monday - Friday  | Timings: 9:00 AM – 5:00 PM Role Overview Responsible for regulatory submissions, product registrations, license renewals, and compliance for medical devices in India and neighboring countries. Supports Quality Management System (QMS), audits, CAPA, supplier/distributor quality, and ensures compliant labeling, documentation, ...

POSITION TITLE: Senior QA/RA SpecialistJOB LOCATION: Bangalore,IndiaDEPARTMENT: Quality & RegulatoryREQUIRED EDUCATION: Bachelor’s degree in biomedical engineering discipline or equivalent engineering degreeKEY RESPONSIBILITIES: ➢ Product QA/RA: • Provide quality and regulatory affairs input to the productdevelopment team and handle all QA & RA responsibilitiesthroughout product development, design change and post marketsurveillance process• As ...

Assist in ensuring product quality and compliance with regulatory standards, including MDR and QMS requirements. Support the preparation and maintenance of quality manuals, formats, and SOPs under guidance. Conduct routine document reviews, including COAs, calibration reports, and sterilization checklists. Participate in internal audits and assist with audit documentation and follow-ups. Maintain and update records ...

Quality Assurance Administration, training, and auditing of Quality System Tools (Customer Complaints, CAPA, Training, Control Documents, Standards). Ensure compliance of quality procedures and work instructions with applicable standards. Conduct audits, training, preventive and corrective actions to maintain the QA system. Maintain training, qualification, and certification records of personnel. Approve/disapprove suppliers, vendors, facilities, equipment, processes, and ...