Key Responsibilities: Analyze and understand PCB BOMs, Gerber files, Pick & Place (PNP) files, and other relevant documents for procurement purposes. Float files to approved PCB vendors for quotation, and proactively follow up for competitive and timely quotes. Handle all vendor communications regarding pricing, lead time, technical clarification, and alternate suggestions. Evaluate incoming quotes for cost, delivery, and part availability; recommend the most optimal procurement strategy. Identify and propose cost-effective alternate components in case of availability or pricing issues by thoroughly studying datasheets and cross-referencing. Coordinate directly with vendors for order tracking, ensuring timely delivery and proper documentation. In specific cases, directly source high-value components from OEMs or authorized distributors to reduce procurement costs. Maintain records of vendor performance and develop a preferred vendor list. Collaborate with the design and production teams to ensure procurement timelines align with project schedules. Flag any risk related to part obsolescence or long lead times and suggest appropriate alternatives. Required Skills & Competencies:Strong understanding of PCB fabrication and assembly processes. Proficiency in reading Gerber files, BOMs, and electronic schematics. Familiarity with electronic components, datasheets, and replacement identification tools. Excellent communication and vendor negotiation skills. Hands-on experience with Excel, component search engines, and procurement CRMs (if any). Strong attention to detail, cost awareness, and problem-solving abilities. Required Skills & Competencies: Strong understanding of PCB fabrication and assembly processes. Proficiency in reading Gerber files, BOMs, and electronic schematics. Familiarity with electronic components, datasheets, and replacement identification tools. Excellent communication and vendor negotiation skills. Hands-on experience with Excel, component search engines, and procurement CRMs (if any). Strong attention to detail, cost awareness, and problem-solving abilities. Qualification & Experience: Diploma or Degree in Electronics Engineering or related discipline. 2–4 years of experience in electronics procurement, especially in PCB sourcing or EMS coordination. Prior experience in vendor management and sourcing from Indian or global component suppliers is a plus.
Qualification: Diploma / Degree in Mechanical Engineering or ITI (Mechanical/Tool & Die) Key Responsibilities: Review and analyze product designs for manufacturability (DFM) specific to plastic injection molding. Design and develop molds and tools for plastic parts, ensuring adherence to product specifications and cost targets. Select appropriate mold materials (e.g., P20, H13, S7, etc.) based on part requirements and production volume. Evaluate and recommend suitable molding materials (e.g., ABS, PC, PP, Nylon, etc.) considering application, performance, and cost. Prepare detailed 2D/3D tool and part drawings using CAD software (SolidWorks/AutoCAD/UG/NX/Catia). Collaborate with product designers to suggest design modifications for improved manufacturability and tool life. Conduct mold flow analysis, gate location selection, cooling channel design, and parting line definition. Troubleshoot and resolve issues during mold trials and production, including warpage, sink marks, and short shots. Coordinate with toolmakers, vendors, and production teams for mold fabrication, assembly, and validation. Ensure compliance with dimensional accuracy, tolerances, and quality standards. Prepare and maintain comprehensive technical documentation, BOM, and design records. Key Skills & Requirements: Strong understanding of DFM principles for injection molded parts. Proficiency in designing injection molds, including multi-cavity and family molds. Hands-on experience with various mold steels (P20, H13, S7, etc.) and plastic materials (ABS, PC, PP, Nylon, etc.). In-depth knowledge of mold flow analysis, cooling system design, and ejection mechanisms. Experience with CAD software (SolidWorks, AutoCAD, UG/NX, Catia, or similar). Ability to interpret and generate technical drawings and GD&T. Excellent problem-solving skills and ability to suggest design/process improvements. Effective communication and coordination with cross-functional teams. Strong attention to detail and quality orientation. Preferred: Exposure to rapid prototyping, 3D printing for trial parts, and advanced manufacturing techniques. Experience in mold maintenance, repair, and modification. Candidates with exposure to other process like vacuum casting and thermoforming will be given preference.
IMPORT OPERATIONS Prepare & verify import documents (commercial invoice, packing list, certificate of origin, BL/AWB, insurance, etc.) Coordinate with overseas vendors for shipment readiness, pre-shipment inspection, and documentation accuracy Liaise with freight forwarders for rate negotiation, space booking, and shipment tracking (air & sea) Interface with Customs House Agents (CHA) for clearance, classification, and timely filing of Bill of Entry Monitor duty exemptions/benefits under Advance Authorisation & EPCG schemes; ensure licence quantities are debited and tracked correctly EXPORT OPERATIONS Issue export invoices and packing lists compliant with buyer and customs requirements Arrange bookings, release carting orders, and ensure timely hand-over to port Coordinate with CHA for checklist approval and customs filing Track BL/AWB issuance and dispatch document sets to buyers/banks BANKING & COMPLIANCE Prepare and submit documents for export bill negotiation / LC presentation and follow-up for acceptance Handle eBRC generation, bank knock-off, inward remittance tracking, and timely closure of outward remittances against BOE Maintain up-to-date knowledge of FEMA, RBI, DGFT, and customs notifications COST & MIS Verify vendor invoices, freight bills, and other landed-cost components; highlight variances for approval Maintain shipment trackers, duty-benefit registers, advance licence utilisation, and monthly MIS dashboards PROCESS IMPROVEMENT Identify opportunities to shorten lead times, reduce demurrage/detention, and optimise documentation flow Train junior staff or interns on customs documentation and ERP/Tally entries
About the Role: We are establishing a new manufacturing unit for medical devices and IVD reagents at YEIDA. As we prepare for licensing and full-scale production, we are hiring a Senior QA/QC & Regulatory Affairs Manager to lead all quality and regulatory activities from day one. This is a critical leadership position responsible for setting up the QMS, ensuring ISO 13485 and MDR 2017 compliance, overseeing product quality, and ensuring audit and licensing readiness. Key Responsibilities: Quality Assurance (QA): Establish and maintain the Quality Management System (QMS) as per ISO 13485 and MDR 2017. Draft, review, and approve SOPs, Quality Manual, DHR, DMR, and related documentation. Oversee implementation of GMP, risk management, and CAPA systems. Lead internal audits, management reviews, and maintain audit preparedness at all times. Ensure compliance with CDSCO, IVD guidelines, and other applicable standards. Quality Control (QC): Supervise raw material, in-process, and final product testing for IVD reagents. Approve test methods, analytical procedures, and equipment qualification protocols. Review batch records, approve Certificate of Analysis (CoA), and stability data. Ensure proper lab setup, calibration of instruments, and environmental monitoring. Regulatory Affairs :Prepare and file regulatory submissions for manufacturing site licensing, product registration, and other statutory filings. Maintain regulatory dossiers as per MDR 2017 and applicable international standards. Serve as the point of contact during inspections and regulatory audits (CDSCO, ISO, etc.). Monitor regulatory updates and implement necessary changes in QMS or product documentation. Team & Facility Oversight: Build and mentor the QA/QC and documentation team. Collaborate with production and R&D to ensure product quality and compliance. Participate in facility planning to ensure compliance with regulatory and quality standards. Key Requirements:7–12 years of experience in QA/QC and Regulatory Affairs in medical device or IVD reagent manufacturing. Strong command over ISO 13485, MDR 2017, CDSCO norms, and GMP compliance. Experience in handling regulatory audits, technical files, and licensing procedures. Sound knowledge of lab practices, contamination control, and analytical techniques. Strong leadership, documentation, and cross-functional coordination skills. Qualifications: M.Sc. / B.Tech / M.Tech in Biotechnology, Biochemistry, Chemistry, or Life Sciences. Certification in ISO 13485 Lead Auditor, Regulatory Affairs, or GMP preferred. What We Offer: A core leadership role in a greenfield manufacturing setup. Ownership of end-to-end quality and regulatory processes. Exposure to international markets and audit frameworks. Long-term career growth in a high-impact, compliant manufacturing environment.
About the Role: We are a medical device manufacturing company setting up a state-of-the-art facility in the Medical Device Park, YEIDA, Greater Noida. We are looking for a proactive and experienced Admin & HR Executive to join us immediately and take charge of all administrative responsibilities during the plant construction and setup phase. This person will play a key role in coordinating vendors, managing documentation, and ensuring seamless handover and installation of facility assets. Key Responsibilities: During Plant Setup (Pre-Operations Phase):Coordinate and monitor construction-related activities on-site – including civil, electrical, HVAC, and interior works. Supervise incoming material for interiors such as AC units, furniture, fixtures, etc. Maintain records of delivery challans, warranty cards, invoices, installation certificates. Ensure timely and proper installation of equipment; coordinate with vendors for rectification in case of defects or damages. Handle daily facility operations including temporary site utilities (electricity, water, security, cleaning). Maintain documentation for statutory compliances related to facility setup. Post-Setup (Operations Phase):Assist management in recruitment, onboarding, and HR policy implementation. Maintain attendance records, leave management, and basic payroll coordination. Manage office supplies, housekeeping, and vendor relationships. Coordinate travel, accommodation, and administrative support for visiting staff or guests. Support licensing, audits, and documentation related to medical device manufacturing operations. Key Requirements: Minimum 7-10 years of experience in Admin or Facility Management; experience in plant/factory setup is highly preferred. Working knowledge of construction coordination, basic electrical & civil work, and vendor management. Strong documentation and record-keeping skills. Exposure to HR processes like hiring, onboarding, and attendance management. Ability to multitask and take initiative in a dynamic environment. Good communication skills (Hindi and English). Exposure to a medical device company will be an added advantage Qualifications: Graduate in any discipline (preferably with a background in Administration or HR). Diploma/Certification in Facility Management or HR is a plus. What We Offer: Opportunity to work in a high-growth, regulated industry. Be a core part of the founding team at a new manufacturing facility. Career progression as the plant scales operations. Any gutka consuming personnel must not apply.
About the Role: We are a growing medical device company setting up a new manufacturing unit in YEIDA, Greater Noida. We are seeking a highly experienced and driven Product Head – Reagent Manufacturing (IVD) to lead our in-house reagent production, ensure regulatory compliance, and establish GMP-grade manufacturing practices. You will be responsible for scaling production, managing the team, ensuring documentation, and maintaining the highest quality standards. Key Responsibilities: Manufacturing & Process Management Lead end-to-end manufacturing of IVD reagents (electrolyte, hematology, or similar). Manage production processes involving filtration, chemical mixing, and batch processing. Define SOPs and ensure strict adherence to quality control and assurance standards. Regulatory & Documentation Maintain comprehensive ISO 13485-compliant documentation. Ensure all processes are aligned with MDR 2017 and other applicable regulatory frameworks. Prepare for and lead regulatory audits (CDSCO, ISO, client inspections). Oversee batch records, stability studies, traceability records, and COA generation. Team & Facility Management Hire, train, and manage manufacturing and quality staff. Oversee reagent production area, ensuring cleanliness, safety, and operational efficiency. Ensure calibration and readiness of all production and lab equipment. Infrastructure & Systems Define system protocols for inventory control, environment monitoring, and waste handling. Ensure proper documentation and tracking systems are in place for all operations. Key Requirements: Minimum 5–10 years of experience in IVD reagent manufacturing – preferably in Hematology, Biochemistry, or Electrolyte reagents. Strong understanding of chemical processes, filtration methods, and contamination control. Deep familiarity with ISO 13485, MDR 2017, and relevant IVD documentation practices. Proven experience in facing audits and handling regulatory compliance independently. Strong leadership, process discipline, and documentation skills. Qualifications: M.Sc. / B.Tech / M.Tech in Biotechnology, Biochemistry, Chemistry, or related fields. Additional certifications in Quality Systems, GMP, or Regulatory Affairs will be preferred. What We Offer:Leadership role in a rapidly growing IVD company. Opportunity to shape a modern reagent manufacturing facility from the ground up. Full ownership of product quality and process implementation. Growth-oriented work environment with long-term career prospects.