Quality Assurance Lead

About the role

Ivy Next is seeking a QA Lead to own and continuously improve its Quality Management System (QMS) for a groundbreaking women‑focused medical device. Reporting to the Head of RA/QA, you will drive quality across the product lifecycle, from production to FDA submission, in a fast‑moving start‑up environment.

Key responsibilities

• Own and evolve the QMS in line with ISO 13485, FDA, EU MDR and related standards.
• Maintain document control for procedures, work instructions, forms and the full document lifecycle.
• Lead selection and implementation of an electronic QMS system.
• Manage supplier qualification, evaluation and ongoing oversight.
• Plan, conduct and lead internal audits and prepare for external audits (notified body, regulatory, customer).
• Handle non‑conformance (NC) and CAPA processes from identification through closure.
• Provide quality oversight of production activities, including process monitoring, in‑process controls, equipment calibration and maintenance.
• Support R&D, verification & validation, and manufacturing teams throughout the product lifecycle.
• Oversee change control (ECR/ECO) and related product documentation.
• Prepare and maintain SOPs and the Design History File (DHF).

Required profile

• Degree in Engineering or a related scientific discipline.
• Several years of proven QA experience within a medical device company (mandatory).
• Strong familiarity with ISO 13485, ISO 14971, IEC 62304, FDA QMSR/21 CFR Part 820 and EU MDR.
• Professional proficiency in English (reading and writing).

Required skills

• ISO 13485
• ISO 14971
• IEC 62304
• FDA 21 CFR Part 820
• EU MDR