Job Title: QA/RA Officer Location: Noida Job Type: Full-time Salary: 40-45 K Job Summary: We are looking for a skilled QA/RA Officer with 3 to 5 years of experience in Quality Assurance within the medical device industry to ensure our products meet regulatory standards and quality requirements. The role involves developing and maintaining technical documentation for regulatory submissions, preparing key files such as Device Master Files, Design History Files, and Risk Management Files, and overseeing the CAPA process. You will also conduct internal audits, identify non-conformities, and support external audits to ensure compliance with ISO 13485, ISO 14971, and other relevant standards. Strong analytical, problem-solving, and communication skills are essential, as is the ability to collaborate with cross-functional teams to ensure continuous improvements in product quality and regulatory compliance. Key Responsibilities: Develop and maintain technical documentation for regulatory submissions. Prepare, review, and implement Standard Operating Procedures (SOPs) and relevant formats. Oversee the Corrective and Preventive Action (CAPA) process to ensure compliance. Conduct internal audits, identify non-conformities, and drive corrective actions. Ensure compliance with global regulatory requirements for medical devices. Support external regulatory audits and inspections. Collaborate with cross-functional teams to enhance product quality and regulatory compliance. Requirements & Qualifications: Bachelor's degree (Biomedical Engineering or a related field). Required Experience 3 to 5 years in Quality Assurance within the medical device industry. Required Knowledge & Skills: Regulatory Standards & Compliance: o ISO 13485 – Quality Management Systems for Medical Devices o ISO 14971 – Risk Management for Medical Devices o ISO 62366 – Usability Engineering for Medical Devices o Indian Medical Device Rules (IMDR) 2017 o Audit Planning & Management for Class B & C Medical Devices Documentation & Technical Writing: o Quality Management System (QMS) Documentation o Device Master File (DMF) Preparation o Site Master File (SMF) Preparation o Design History File (DHF) Preparation (ISO 13485) o Risk Management File (ISO 14971) o Usability Engineering Report (ISO 62366) Job Type: Full-time Pay: ₹400,000.00 - ₹500,000.00 per year Benefits: Provident Fund Schedule: Morning shift Ability to commute/relocate: Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (Preferred) Experience: Medical: 3 years (Preferred) Work Location: In person Application Deadline: 02/08/2025 Expected Start Date: 25/07/2025
Job Title: Telecaller / Telemarketing Executive Location: Noida Sector 83 Job Type: Full-time / Part-time Industry: Medical / Manufacturing Job Summary: We are seeking a motivated and results-driven Telecaller to join our team. The Telecaller will be responsible for reaching out to potential or existing customers to inform them about products or services, generate sales, or gather information. Key Responsibilities: Make outbound calls to prospective customers or clients. Respond to incoming calls from customers. Provide accurate information about products/services. Understand customer needs and provide appropriate solutions. Maintain a database of customer contact information. Follow up with potential leads and maintain client relationships. Meet daily/weekly/monthly call and conversion targets. Record call details and update CRM systems. Requirements: High school diploma or equivalent; a bachelor’s degree is a plus. Proven experience as a telecaller or similar role is preferred. Excellent communication and interpersonal skills. Fluency in English. Basic computer knowledge and familiarity with CRM tools. Ability to handle rejection and remain positive. Goal-oriented and self-motivated. Job Types: Full-time, Permanent Pay: ₹18,000.00 - ₹22,000.00 per month Benefits: Provident Fund Schedule: Morning shift Experience: Inside sales: 1 year (Preferred) Language: English (Preferred) Work Location: In person Application Deadline: 02/08/2025 Expected Start Date: 25/07/2025
Job Title: QA/RA Officer Location: Noida Job Type: Full-time Salary: 40-45 K Job Summary: We are looking for a skilled QA/RA Officer with 3 to 5 years of experience in Quality Assurance within the medical device industry to ensure our products meet regulatory standards and quality requirements. The role involves developing and maintaining technical documentation for regulatory submissions, preparing key files such as Device Master Files, Design History Files, and Risk Management Files, and overseeing the CAPA process. You will also conduct internal audits, identify non-conformities, and support external audits to ensure compliance with ISO 13485, ISO 14971, and other relevant standards. Strong analytical, problem-solving, and communication skills are essential, as is the ability to collaborate with cross-functional teams to ensure continuous improvements in product quality and regulatory compliance. Key Responsibilities: Develop and maintain technical documentation for regulatory submissions. Prepare, review, and implement Standard Operating Procedures (SOPs) and relevant formats. Oversee the Corrective and Preventive Action (CAPA) process to ensure compliance. Conduct internal audits, identify non-conformities, and drive corrective actions. Ensure compliance with global regulatory requirements for medical devices. Support external regulatory audits and inspections. Collaborate with cross-functional teams to enhance product quality and regulatory compliance. Requirements & Qualifications: Bachelor's degree (Biomedical Engineering or a related field). Required Experience 3 to 5 years in Quality Assurance within the medical device industry. Required Knowledge & Skills: Regulatory Standards & Compliance: o ISO 13485 – Quality Management Systems for Medical Devices o ISO 14971 – Risk Management for Medical Devices o ISO 62366 – Usability Engineering for Medical Devices o Indian Medical Device Rules (IMDR) 2017 o Audit Planning & Management for Class B & C Medical Devices Documentation & Technical Writing: o Quality Management System (QMS) Documentation o Device Master File (DMF) Preparation o Site Master File (SMF) Preparation o Design History File (DHF) Preparation (ISO 13485) o Risk Management File (ISO 14971) o Usability Engineering Report (ISO 62366) Job Type: Full-time Pay: ₹400,000.00 - ₹500,000.00 per year Benefits: Provident Fund Schedule: Morning shift Ability to commute/relocate: Noida, Uttar Pradesh: Reliably commute or planning to relocate before starting work (Preferred) Experience: Medical: 3 years (Preferred) Work Location: In person Application Deadline: 02/08/2025 Expected Start Date: 25/07/2025
Job Title: Service Engineer Job Type: Full time Salary: 18-22 K Job Summary: We are looking for a dedicated and technically skilled Service Engineer with a diploma in Electrical Engineering to join our team. The ideal candidate will be responsible for installation, maintenance, troubleshooting, and repair of our equipment at client sites, ensuring customer satisfaction and operational excellence. Key Responsibilities: · Install, commission, and maintain electrical/electronic equipment at client locations. · Diagnose and troubleshoot electrical and mechanical faults in the field. · Provide on-site technical support and training to clients. · Maintain detailed service records and prepare reports. · Coordinate with internal teams for parts replacement and service support. · Ensure adherence to company safety protocols and quality standards. · Respond promptly to service requests and emergency breakdowns. · Conduct preventive maintenance visits as scheduled. · Keep up-to-date with product knowledge and technical developments. Requirements & Qualifications: · Strong problem-solving and analytical skills. · Good communication and customer-handling abilities. · Ability to work independently and travel to customer sites. · Time management and documentation skills. · Willingness to travel extensively (within the region or nationally). · Two-wheeler license preferred (if applicable). · Familiarity with safety protocols and industrial environments. · Diploma in Electrical Engineering (mandatory). · 1–3 years of relevant experience in service/maintenance (freshers with strong fundamentals may also apply). · Good understanding of electrical systems, wiring diagrams, and troubleshooting techniques. · Basic knowledge of PLCs, drives, or industrial automation is a plus. · Ability to read and interpret technical documents and schematics. · Proficiency with hand tools, Multi-meters, and testing instruments Job Types: Full-time, Permanent Pay: ₹18,000.00 - ₹22,000.00 per month Benefits: Cell phone reimbursement Internet reimbursement Provident Fund Schedule: Morning shift Willingness to travel: 100% (Preferred) Work Location: Remote Application Deadline: 10/08/2025 Expected Start Date: 30/07/2025
As a QA/RA Officer at our company, you will utilize your 3 to 5 years of experience in Quality Assurance within the medical device industry to ensure that our products meet regulatory standards and quality requirements. Your key responsibilities will include developing and maintaining technical documentation for regulatory submissions, preparing essential files like Device Master Files, Design History Files, and Risk Management Files, as well as overseeing the Corrective and Preventive Action (CAPA) process. Internal audits, identification of non-conformities, and support for external audits to maintain compliance with ISO 13485, ISO 14971, and other relevant standards will be part of your role. Your strong analytical, problem-solving, and communication skills will be crucial, along with the ability to collaborate with cross-functional teams for continuous improvement in product quality and regulatory compliance. You will be responsible for developing and maintaining technical documentation for regulatory submissions, reviewing and implementing Standard Operating Procedures (SOPs) and relevant formats, overseeing the CAPA process, conducting internal audits, identifying non-conformities, and ensuring compliance with global regulatory requirements for medical devices. Additionally, you will support external regulatory audits and inspections, collaborate with cross-functional teams, and contribute to enhancing product quality and regulatory compliance. To excel in this role, you should hold a Bachelor's degree in Biomedical Engineering or a related field, possess 3 to 5 years of experience in Quality Assurance within the medical device industry, and have knowledge of regulatory standards and compliance, including ISO 13485, ISO 14971, ISO 62366, Indian Medical Device Rules (IMDR) 2017, and Audit Planning & Management for Class B & C Medical Devices. Your expertise in documentation and technical writing, such as Quality Management System (QMS) Documentation, Device Master File (DMF) Preparation, Site Master File (SMF) Preparation, Design History File (DHF) Preparation (ISO 13485), Risk Management File (ISO 14971), and Usability Engineering Report (ISO 62366), will be valuable in this position. This is a full-time position based in Noida, Uttar Pradesh, with a salary range of 40-45 K. The job offers benefits such as Provident Fund, follows a morning shift schedule, and requires in-person work. If you are reliable in commuting to Noida or planning to relocate before the expected start date of 25/07/2025, we encourage you to apply before the application deadline of 02/08/2025.,