key Responsibilities

1. Design & Development Oversight

Review and approve design inputs, outputs, CAD models, BOMs, and technical documentation. Oversee maintenance of Design History Files (DHF), Risk Management Files (RMF), and other regulatory documentation.

Ensure design control activities are executed effectively across the product lifecycle, from concept to commercialization.

Guide design transfer activities from R&D; to manufacturing, ensuring manufacturability and robustness.

1. Quality & Compliance

Ensure compliance with global regulations and standards, including FDA 21 CFR Part 820, ISO 13485, ISO 14971, and IEC 62366. Provide oversight on risk management activities (e.g., FMEA) and design validation/verification processes.

Manage design-related non-conformances, CAPAs, and engineering change control activities.

Support internal and external audits,



including FDA and ISO inspections, by ensuring design and quality documentation is accurate and audit-ready.

1. Team Management & Collaboration

Drive cross-functional collaboration with R&D;, QA, Manufacturing, and Regulatory Affairs. Ensure effective communication of design progress, risks, and mitigation strategies to senior leadership.

Promote a culture of accountability, innovation, and regulatory excellence within the design team.

Qualifications

- Bachelor's degree or equivalent in Mechanical, Electrical, or Manufacturing Engineering
- 4+ years' of industry experience
- Solid knowledge of quality tools used in the industry
- Analytical and quantitative approach to problem solving

📌 Quality Engineer (Rajkot)
🏢 Alkem MedTech Private
📍 Rajkot