Role & Responsibilities

Draft and revise Standard Operating Procedures (SOPs), work instructions, forms, and quality records aligned to ISO 13485:2016, working within an established Qualio eQMS workplace

Author and maintain quality documentation across ISO 13485 clause areas including document control, risk management (ISO 14971), CAPA, change control, supplier controls, and internal audit records scope will vary week to week based on QMS build-out priorities

Perform gap reviews of existing quality documentation and identify remediation actions

Work autonomously on assigned deliverables, managing your own workload against agreed weekly milestones

Prepare meeting notes, action logs, and structured written summaries following internal and client meetings

Maintain project task trackers and status spreadsheets, keeping deliverables, owners, and deadlines up to date





Draft written responses and updates for client communication channels (e.g. Teams messages), for review before sending

Communicate progress clearly in written English through async written updates on a defined cadence

Support ad hoc quality and documentation tasks as they arise, including responses to Notified Body or auditor queries

Contribute to continuous improvement of internal templates, checklists, and working practices as part of a growing India-based delivery team

This is a fixed-term engagement running to end October, with solid potential for extension or transition into ongoing consultancy delivery work based on performance and business needs.

📌 Senior Quality Assurance Specialist Bengaluru (India)
🏢 EK Medical
📍 India