Job Title: Head – Quality Assurance & Regulatory Affairs (Medical Devices) Location: Visakhapatnam /Chennai Position Type: Full-Time Experience Level: Senior (Individual Contributor + Leadership Oversight) Reports To: CEO / COO / Head of Operations About the Role We are looking for a highly experienced and execution-driven QA/RA professional to lead our Quality and Regulatory function as we scale medical device manufacturing under FDA and EU MDR frameworks. This role is ideal for someone who combines deep regulatory expertise with a hands-on approach —someone who leads by doing, not just directing. You will be responsible for establishing and maintaining the entire Quality Management System (QMS) , ensuring regulatory compliance, and guiding the company through audits, certifications, and product registrations—while also being actively involved on the ground with documentation, process qualification, and compliance monitoring. Key Responsibilities Own and lead all aspects of Quality Assurance and Regulatory Affairs for medical device manufacturing and compliance Establish, implement, and maintain a fully compliant QMS aligned with ISO 13485 , FDA 21 CFR Part 820 , and EU MDR requirements Prepare and manage technical documentation , regulatory submissions , design dossiers , risk files , and CE/FDA pathways Act as the Management Representative for audits, inspections, and regulatory communications Lead internal audits , CAPAs , nonconformance investigations , and supplier qualification processes Oversee validation and qualification protocols (equipment, process, software) and ensure traceability and documentation control Guide the team through design transfer and ensure manufacturing readiness Develop and enforce quality culture across functions and teams Provide strategic regulatory guidance while staying actively involved in the execution of QA/RA tasks Qualifications Bachelor's or Master’s degree in Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field 7–12 years of experience in medical device QA/RA , with at least 3+ years in a leadership role Proven track record of working with FDA (QSR) , ISO 13485 , and EU MDR frameworks Experience in leading regulatory submissions for 510(k), CE Marking, and ISO audits Strong documentation, technical writing, and compliance skills Comfortable being hands-on: writing procedures, reviewing records, attending floor-level quality issues Excellent communication and leadership skills; able to interface with auditors, regulators, and internal teams Experience in a start-up or scale-up manufacturing environment is a strong plus What We’re Looking For A doer and leader who takes ownership and drives outcomes Someone who can build and lead systems , but also get into the details when required A compliance-focused mindset with the practicality to operate in a dynamic environment Someone passionate about building safe, effective, and regulatory-compliant medical technologies To Apply: Please send your resume and a short note on your most relevant QA/RA leadership experience to hr@adiuvodiagnostics.com Show more Show less
Company: Adiuvo Diagnostics Private Limited About Us: Adiuvo Diagnostics Private Limited, an ISO 13485:2016 QMS company, is a leader in developing innovative medical devices. We are seeking a Regulatory Head to oversee end-to-end regulatory affairs, ensuring compliance with US FDA, EU MDR, and Indian CDSCO requirements. Key Responsibilities: Seeking an experienced Mechanical Design Engineer with a background in new product development (NPD) for consumer electronics or medical devices. Key Responsibilities: Lead NPD Projects – Manage electro-mechanical and opto-mechanical design projects, ensuring adherence to budgets and timelines. CAD & Design Optimization – Proficient in Autodesk Fusion 360 and SolidWorks; optimize designs for manufacturability. Technical Documentation – Develop detailed specifications, GD&T, and manufacturing drawings. Simulation & Analysis – Use tools like Ansys for simulations, tolerance stack-up, and optical design analysis. Manufacturability – Apply DFM/DFA principles; experience with additive manufacturing and 3D printing. Material & Prototyping – Select materials and conduct prototyping/testing. Compliance Standards – Familiar with ISO 13485 and relevant medical device standards. Communication & Presentation – Strong technical communication and rendering skills. Qualifications: 2-4+ years in mechanical design engineering, NPD focus Strong understanding of mechanical principles and optical components
The Production Lead will oversee end-to-end manufacturing operations for active medical devices, ensuring smooth, efficient, and cost-effective production while maintaining compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and GMP requirements. While regulatory submissions are handled separately, this role ensures production-level compliance, process validation, and continuous improvement in the shop floor environment. Key Responsibilities Production Management Plan and execute daily/weekly/monthly production schedules aligned with demand forecasts. Manage assembly, integration, and testing of active medical devices to meet quality and delivery commitments. Ensure cleanroom operations and adherence to production SOPs. Drive equipment qualification and process validation (IQ, OQ, PQ) at the production floor. Monitor and improve key production metrics: yield, first-pass success rate, downtime, scrap rate, and productivity . Ensure timely availability of materials, spares, and consumables by coordinating with supply chain. Support design transfer to production , ensuring prototypes scale effectively into full manufacturing. Production-Level Compliance & Quality Ensure production floor compliance with ISO 13485, GMP, and device master record (DMR)/device history record (DHR) requirements. Oversee in-process quality checks , functional testing, and batch release readiness. Implement CAPA, change control, and training programs for production teams. Collaborate with QA to ensure timely audit readiness , focusing on production-level practices. Maintain production documentation, validation records, and traceability. Team & Leadership Supervise production staff, technicians, and line engineers. Train and mentor the production team on good documentation practices (GDP), cleanroom behavior, and regulatory compliance . Drive a culture of continuous improvement in manufacturing operations. Act as the point person for production issues during customer visits, audits, and inspections. Qualifications and Experience Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical) or equivalent. 5+ years of experience in medical device production/manufacturing, preferably active devices. Strong knowledge of production planning, assembly/test operations, and GMP compliance . Hands-on experience with process validation, equipment qualification, and cleanroom manufacturing . Familiarity with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971. Proven ability to lead teams , solve production problems, and ensure regulatory compliance in manufacturing. Key Competencies Production floor leadership with strong operational discipline . Knowledge of lean manufacturing and continuous improvement methodologies. Ability to balance throughput, cost control, and compliance . Strong interpersonal and problem-solving skills to manage cross-functional challenges.
Role Overview We are looking for a detail-oriented and hands-on Assemble Engineer to support the production, assembly, testing, and integration of medical devices and hardware systems. The role involves working closely with the production and R&D teams to assemble electronic and hardware components, ensure quality standards, troubleshoot issues, and contribute to continuous improvements in assembly processes. Key Responsibilities Assemble electronic, hardware, and electro-mechanical components of medical devices as per design drawings, schematics, and SOPs. Perform PCB assembly, soldering, wiring, cabling, and connector integration . Assemble and integrate optical, electronic, and mechanical modules into final device builds. Conduct functional and quality testing on assembled units to ensure compliance with defined standards. Maintain production records, assembly checklists, and test reports . Troubleshoot and resolve assembly issues in coordination with R&D/Engineering teams. Follow ESD protocols, cleanroom practices, and Good Manufacturing Practices (GMP) . Support prototype builds, pilot production, and scaling to manufacturing . Ensure safety, calibration, and upkeep of tools/equipment used in assembly. Collaborate with cross-functional teams (Production, QA, R&D) to improve assembly efficiency and quality. Qualifications & Experience Diploma / Bachelor’s degree in Electronics, Electrical, Mechatronics, or related field . 2–4 years of hands-on experience in electronics/hardware assembly (medical devices preferred). Skilled in PCB handling, soldering, wiring, and assembling electronic modules . Familiarity with mechanical fitting, optical alignment, or device integration is an advantage. Knowledge of ISO 13485, GMP, and medical device quality requirements desirable. Strong attention to detail, good documentation practices, and teamwork mindset. Key Competencies Hands-on assembly skills (electronics + hardware). Ability to read schematics, wiring diagrams, and CAD drawings . Troubleshooting mindset and problem-solving skills. Willingness to work in a fast-paced startup environment with flexibility and ownership.
The Production Lead will oversee end-to-end manufacturing operations for active medical devices (USFDA Approved), ensuring smooth, efficient, and cost-effective production while maintaining compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and GMP requirements. While regulatory submissions are handled separately, this role ensures production-level compliance, process validation, and continuous improvement in the shop floor environment. Key Responsibilities Production Management Plan and execute daily/weekly/monthly production schedules aligned with demand forecasts. Manage assembly, integration, and testing of active medical devices to meet quality and delivery commitments. Ensure cleanroom operations and adherence to production SOPs. Drive equipment qualification and process validation (IQ, OQ, PQ) at the production floor. Monitor and improve key production metrics: yield, first-pass success rate, downtime, scrap rate, and productivity . Ensure timely availability of materials, spares, and consumables by coordinating with supply chain. Support design transfer to production , ensuring prototypes scale effectively into full manufacturing. Production-Level Compliance & Quality Ensure production floor compliance with ISO 13485, GMP, and device master record (DMR)/device history record (DHR) requirements. Oversee in-process quality checks , functional testing, and batch release readiness. Implement CAPA, change control, and training programs for production teams. Collaborate with QA to ensure timely audit readiness , focusing on production-level practices. Maintain production documentation, validation records, and traceability. Team & Leadership Supervise production staff, technicians, and line engineers. Train and mentor the production team on good documentation practices (GDP), cleanroom behavior, and regulatory compliance . Drive a culture of continuous improvement in manufacturing operations. Act as the point person for production issues during customer visits, audits, and inspections. Qualifications and Experience Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical) or equivalent. 5+ years of experience in medical device production/manufacturing, preferably active devices. Strong knowledge of production planning, assembly/test operations, and GMP compliance . Hands-on experience with process validation, equipment qualification, and cleanroom manufacturing . Familiarity with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971. Proven ability to lead teams , solve production problems, and ensure regulatory compliance in manufacturing. Key Competencies Production floor leadership with strong operational discipline . Knowledge of lean manufacturing and continuous improvement methodologies. Ability to balance throughput, cost control, and compliance . Strong interpersonal and problem-solving skills to manage cross-functional challenges.
The Production Lead will oversee end-to-end manufacturing operations for active medical devices (USFDA Approved), ensuring smooth, efficient, and cost-effective production while maintaining compliance with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and GMP requirements. While regulatory submissions are handled separately, this role ensures production-level compliance, process validation, and continuous improvement in the shop floor environment. Key Responsibilities Production Management Plan and execute daily/weekly/monthly production schedules aligned with demand forecasts. Manage assembly, integration, and testing of active medical devices to meet quality and delivery commitments. Ensure cleanroom operations and adherence to production SOPs. Drive equipment qualification and process validation (IQ, OQ, PQ) at the production floor. Monitor and improve key production metrics: yield, first-pass success rate, downtime, scrap rate, and productivity . Ensure timely availability of materials, spares, and consumables by coordinating with supply chain. Support design transfer to production , ensuring prototypes scale effectively into full manufacturing. Production-Level Compliance & Quality Ensure production floor compliance with ISO 13485, GMP, and device master record (DMR)/device history record (DHR) requirements. Oversee in-process quality checks , functional testing, and batch release readiness. Implement CAPA, change control, and training programs for production teams. Collaborate with QA to ensure timely audit readiness , focusing on production-level practices. Maintain production documentation, validation records, and traceability. Team & Leadership Supervise production staff, technicians, and line engineers. Train and mentor the production team on good documentation practices (GDP), cleanroom behavior, and regulatory compliance . Drive a culture of continuous improvement in manufacturing operations. Act as the point person for production issues during customer visits, audits, and inspections. Qualifications and Experience Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical) or equivalent. 5+ years of experience in medical device production/manufacturing, preferably active devices. Strong knowledge of production planning, assembly/test operations, and GMP compliance . Hands-on experience with process validation, equipment qualification, and cleanroom manufacturing . Familiarity with ISO 13485:2016, FDA QSR (21 CFR Part 820), EU MDR, and ISO 14971. Proven ability to lead teams , solve production problems, and ensure regulatory compliance in manufacturing. Key Competencies Production floor leadership with strong operational discipline . Knowledge of lean manufacturing and continuous improvement methodologies. Ability to balance throughput, cost control, and compliance . Strong interpersonal and problem-solving skills to manage cross-functional challenges.
Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing state-of-the-art platform technologies in optoelectronics. Our mission is to aid early disease detection and to enable advanced healthcare diagnostics in low-resource settings. We strive to bring cutting-edge diagnostic technologies to the places they are needed most. Job Description We are seeking a highly driven Principal Engineer & Head of R&D (Hardware & Optics) to lead the development of next-generation medical diagnostic devices. This role requires a unique blend of hands-on technical expertise, cross-disciplinary knowledge, and leadership skills. The ideal candidate will not only design and execute cutting-edge R&D projects but also build and mentor a strong engineering team to deliver seamless innovation from concept to commercialization. Key Responsibilities Lead end-to-end R&D activities in hardware, optical systems, and device integration. Design, prototype, and validate novel hardware and optics solutions for imaging and diagnostic platforms. Translate product requirements into scalable technical designs in close collaboration with software, clinical, and regulatory teams. Build, guide, and mentor a multi-disciplinary team, fostering a culture of innovation and accountability. Oversee data-driven design decisions, ensuring precision, robustness, and compliance with regulatory standards. Drive experimental design, testing, and validation, including wet-lab support and cross-functional collaborations. Develop and maintain documentation required for regulatory submissions (FDA, CE, CDSCO). Manage project timelines, resource planning, and vendor coordination while staying hands-on with technical problem solving. Represent R&D leadership in discussions with external partners, investors, and collaborators. Key Qualifications Master’s or PhD in Electronics, Optics, Physics, Biomedical Engineering, or related field. Strong technical expertise in hardware systems, optical instrumentation, sensors, and imaging technologies. Proven experience in leading experimental design, prototyping, and lab-based validation. Ability to manage and mentor engineers/scientists, while remaining hands-on in solving complex technical problems. Familiarity with regulatory documentation (e.g., ISO 13485, IEC 60601, FDA/CE submissions). Strong analytical mindset with ability to assimilate and interpret data. Excellent communication skills, with ability to collaborate across clinical, regulatory, and commercial teams. Prior experience in medical devices, diagnostics, or imaging platforms is highly desirable. Why Join Us? This is not a “manager-only” role — it is a hands-on leadership position at the heart of innovation. You will directly shape cutting-edge products, learn continuously across disciplines, and play a pivotal role in building a high-performance R&D organization.
Company Description Adiuvo Diagnostics is a techno-social enterprise focused on developing state-of-the-art platform technologies in optoelectronics. Our mission is to aid early disease detection and to enable advanced healthcare diagnostics in low-resource settings. We strive to bring cutting-edge diagnostic technologies to the places they are needed most. Job Description We are seeking a highly driven Principal Engineer & Head of R&D (Hardware & Optics) to lead the development of next-generation medical diagnostic devices. This role requires a unique blend of hands-on technical expertise, cross-disciplinary knowledge, and leadership skills. The ideal candidate will not only design and execute cutting-edge R&D projects but also build and mentor a strong engineering team to deliver seamless innovation from concept to commercialization. Key Responsibilities Lead end-to-end R&D activities in hardware, optical systems, and device integration. Design, prototype, and validate novel hardware and optics solutions for imaging and diagnostic platforms. Translate product requirements into scalable technical designs in close collaboration with software, clinical, and regulatory teams. Build, guide, and mentor a multi-disciplinary team, fostering a culture of innovation and accountability. Oversee data-driven design decisions, ensuring precision, robustness, and compliance with regulatory standards. Drive experimental design, testing, and validation, including wet-lab support and cross-functional collaborations. Develop and maintain documentation required for regulatory submissions (FDA, CE, CDSCO). Manage project timelines, resource planning, and vendor coordination while staying hands-on with technical problem solving. Represent R&D leadership in discussions with external partners, investors, and collaborators. Key Qualifications Masters or PhD in Electronics, Optics, Physics, Biomedical Engineering, or related field. Strong technical expertise in hardware systems, optical instrumentation, sensors, and imaging technologies. Proven experience in leading experimental design, prototyping, and lab-based validation. Ability to manage and mentor engineers/scientists, while remaining hands-on in solving complex technical problems. Familiarity with regulatory documentation (e.g., ISO 13485, IEC 60601, FDA/CE submissions). Strong analytical mindset with ability to assimilate and interpret data. Excellent communication skills, with ability to collaborate across clinical, regulatory, and commercial teams. Prior experience in medical devices, diagnostics, or imaging platforms is highly desirable. Why Join Us This is not a manager-only role it is a hands-on leadership position at the heart of innovation. You will directly shape cutting-edge products, learn continuously across disciplines, and play a pivotal role in building a high-performance R&D organization. Show more Show less