Senior Quality Lead / Senior Engineer / Assistant Manager Quality As Innvolution Healthcare

5.0 - 10.0 years

7 - 10 Lacs

Bengaluru

Work from Office

Role & responsibilities We are looking for a highly skilled and motivated Senior Quality Lead / Senior Engineer / Assistant Manager Quality Assurance to join our dynamic team in Bangalore . Key Responsibilities: Prepare, review, and maintain QMS documentation in line with ISO 13485. Conduct root cause analysis of non-conformances and implement CAPA. Support regulatory and certification audits (ISO 13485, CE, US FDA, etc.). Conduct internal audits and ensure timely closure of findings. Facilitate management review meetings and prepare related documentation. Maintain Design History Files (DHF) and Device Master Records (DMR). Review and validate engineering change requests (ECR/ECN). Lead validation/verification activities for processes, jigs/fixtures, and software. Participate in design reviews and support new product introductions (NPI). Ensure compliance with NABL 17025, EU MDR, US FDA, and IMDR. Administer DMS tool and support product registration in domestic & international markets. Conduct supplier qualification, process audits, and product risk assessments. Mandatory Qualifications: B.E / B.Tech / Diploma in Mechanical, Electrical, Biomedical, or Industrial Engineering. Alternatively, Postgraduate degree in Engineering, Medical Physics, Regulatory Affairs, or Quality Management. Strong knowledge of ISO 13485, ISO 14971, IEC 62304 , and NABL 17025 . Experience in technical documentation, QMS, statistical tools, validations, and internal audits. Professional Skills: Strong documentation and QMS implementation experience. Proficiency in 7QC tools, calibration, verification, and process control. Familiar with CE marking, FDA regulations, and EU MDR compliance. Experience handling audit findings and regulatory submissions Preferred candidate profile Mandatory Skill: ISO 13485, ISO 14971, IEC 62304 , and NABL 17025 Interested candidates are encouraged to apply immediately or within 15 days of their notice period vijayakumar.ramachandran@innvolution.com

Posted 3 weeks ago

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Senior Embedded Software Engineer (Medical Devices) Innoiq Engineering

4.0 - 8.0 years

8 - 15 Lacs

Pune

Hybrid

Job Title: Embedded Software Engineer Medical Device Technology Location: Pune Department: Engineering / Embedded Systems Employment Type: Full Time Company Overview: InnoIQ Engineering , a subsidiary of B&W Engineering und Datensysteme GmbH, Germany , is a leading company specializing in the research, design, and development of innovative medical devices . With a strong focus on precision, quality, and customer-centric solutions , we collaborate with global clients to bring advanced medical technologies to life. From concept design and prototyping to production support , we offer comprehensive engineering solutions tailored for the medical device industry . Position Summary: We are seeking a passionate and detail-oriented Embedded Software Engineer to join our growing engineering team. You will play a critical role in the development of embedded software solutions for cutting-edge medical devices , ensuring compliance with regulatory standards and delivering high-quality products that positively impact patient care. Key Responsibilities: Design, develop, test, and maintain embedded software for medical devices Collaborate with cross-functional teams including electronics, mechanical, and system engineers Write efficient, reliable, and reusable code in C/C++ for embedded platforms Contribute to software architecture and system integration for real-time embedded systems Conduct software verification, validation, and unit testing in accordance with IEC 62304 Support design documentation and risk management activities per ISO 13485 and ISO 14971 Debug hardware/software integration issues using appropriate tools and methods Participate in design reviews, code reviews, and continuous improvement activities Required Qualifications: Bachelors or Masters degree in Electronics Engineering , Computer Engineering , Embedded Systems , or related field 2+ years of experience in embedded software development , preferably in the medical device domain Proficiency in C/C++ programming and real-time embedded systems Experience with microcontrollers , RTOS , and hardware-software interfacing Strong understanding of software development life cycle in regulated environments Knowledge of medical standards such as IEC 62304 , ISO 13485 , and ISO 14971 Good problem-solving skills and attention to detail Proficient in written and spoken English Preferred Qualifications: Experience with wireless communication protocols BLE, NFC Familiarity with version control systems Git and tools like Jira, Confluence Experience in developing software under Agile or V-model process Why Join Us? Be part of a global team developing life-enhancing medical technologies Work in a culture that values innovation , precision , and continuous learning Opportunities to grow in a fast-paced , quality-driven , and regulatory-compliant environment Exposure to international projects and collaboration with leading medical device companies

Posted 2 months ago

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