Regulatory Affairs & Quality Assurance Engineer – Siemens Healthineers – Pune – Experienced

🚨 Hiring Alert – Regulatory Affairs & Quality Assurance Engineer

Siemens Healthineers is seeking an experienced RA/QA Engineer to join their team in Pune. This is a fantastic opportunity to play a key role in ensuring the highest standards of quality and compliance in cutting-edge healthcare technologies. Join a global team that values innovation, diversity, and sustainable healthcare solutions.

👉Apply Now: https://tinyurl.com/2wvx4zx6

As an RA/QA Engineer, you will be responsible for ensuring compliance with domestic and international regulations, supporting design and development teams, and minimizing risks associated with medical device design and realization. You will participate in design reviews, manage quality documentation, support audits, and provide guidance on design verification, validation, and statistical analysis. This role involves collaborating across teams to ensure smooth product transfer to manufacturing and supporting regulatory submissions such as FDA 510(k). You will also oversee post-market surveillance, analyze complaint data, and contribute to continuous process improvement while mentoring teams on compliance and quality practices.

📍 Job Location: Pune, India

💻 Product Segment: Quality Assurance & Regulatory Affairs

🎓 Qualification:Bachelor’s/Master’s in Computer Science or Engineering with 4 – 6 years’ experience in healthcare software or medical device regulations, knowledge of ISO 13485, ISO 14971, IEC 62304, FDA QSR, and related standards. Certifications like SQA or ISO 13485 Internal/Lead Auditor are an added advantage.

💰 Salary: 12.0 to 15.0 LPA

🌐 Employer Website: https://www.siemens-healthineers.com/en-in

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👉Apply Now: https://tinyurl.com/2wvx4zx6