- Support the continual development, improvement, implementation and maintenance of the organization’s Information Security Management System (ISMS) and Quality Management System (QMS).

- Define, implement, review and maintain the organizational quality & information security policies, processes, procedures and controls in line with ISO 27001:2013, ISO 13485:2016 standards.

- Responsible for document and record control, review, issue, retrieval & superseding of all SOP and other.

- Collaborate with internal stakeholders for implementing controls and processes for respective functions and ensure continuous operating effectiveness of the defined procedures.

- Awareness of Medical Device standards & regulations - ISO 13485, ISO 14971, IEC 62304, SaMD, IEC 82304, CE, 21 CFR 820 – Design Controls, 510(k), MDR, TGA ARGMD and others.

- Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.

- Conduct / participate in Internal and External Audits.





- Coordinate and ensure timely closure of audit findings.

- Initiate and moderate the root cause analysis and monitor effective and timely implementation of CAPA.

- Analyze data to identify trends and opportunities for improvement on quality aspects.

- Conduct Information Security / Quality Management System Awareness and Training programs for employees as a part of their induction and regular awareness.

- Support on process improvement and continuous improvement activities.

- Drive process compliance in the complete lifecycle process of the medical device, mainly Software.

- Collaborate and consult product team members in implementing and realizing the processes.

- Collaborate and coordinate with cross functional team to review technical documents.

- Ensures product compliance with legal and normative requirements.

- Drive best practices within the organization

📌 JD - Quality Engineer (Hyderabad)
🏢 Bay Mortgage Services
📍 Hyderabad