Description

Manage quality compliance and remediation activities for regulated medical devices. Harmonize QMS across sites and maintain procedures for CAPA, complaints, supplier quality, audits, and risk.

Responsibilities

• Support QMS integration across sites to create a harmonized system.
• Maintain quality procedures and work instructions for CAPA, complaints, supplier quality, internal audit, and risk.
• Execute remediation support for Design History Files (DHF), design content, risk files, and cybersecurity artifacts.
• Coordinate with cross-functional teams to review inputs, identify gaps, and close remediation tasks.
• Assist with LMS implementation, data migration validation, and document migration validation.

Required Skills

• Working knowledge of ISO 13485, MDSAP, EU MDR 2017/745, and US FDA 21 CFR Part 820.
• Experience with ISO 14971, IEC 62304, and IEC 62366 standards.
• Proficiency in Design (DHF), design content, risk files, and cybersecurity quality artifacts.
• Working proficiency with Microsoft Office, including Excel, PowerPoint, Outlook, and Teams.
• Ability to manage and report on complex tasks with minimal supervision.
• Strong English verbal and written communication skills for virtual stakeholder interaction.
• Proven ability to work under pressure and meet tight timelines.
• Any graduate degree.

Preferred Skills

• Experience managing process compliance to meet delivery timelines.
• Experience resolving technical queries in a regulated environment.

Key Skills

Education

Any graduate