Quality Assurance Lead

Ivy Next has developed a revolutionary technology that lets women be examined in gynecological procedures without a bi-valve speculum or stirrups. It’s not just a new way to examine, it’s the first step toward real, lasting change in women’s healthcare, and in how women experience it. We’re a small team taking on a big mission, and we’re looking for people who want to help build it from the ground up.

We’re at one of the most exciting points a company can be, the stretch before entering the market and building the team who will help take us there.

We are looking for talented individuals who are eager to take ownership, contribute meaningfully, and play an active role in shaping the company’s journey.

Description

We’re looking for a QA Lead to take full ownership of Ivy Next QMS. It’s a true end-to-end role, you’ll build and run our QMS, manage documentation and change control, lead our suppliers and audits, and be the person the whole team trusts to keep quality on track, from the production floor to our FDA submission.

You will report directly to the Head of RA/QA and will be trusted to lead the QA domain independently, in a dynamic, fast-moving start-up environment where requirements and priorities can change quickly.

Key Responsibilities

• Own and continuously improve our Quality Management System (QMS), in line with the medical device standards that matter (ISO 13485, FDA, EU MDR, and others).
• Keep an eye on regulatory changes and make sure our QMS evolves with them.
• Own document control end-to-end: procedures, work instructions, forms, and the full document lifecycle.
• Lead the selection and implementation of an electronic QMS system.
• Manage supplier qualification, evaluation, and ongoing oversight.
• Plan, manage, and lead internal audits, and prepare the organization for external audits (notified body, regulatory, customer).
• Own non-conformance (NC) handling and CAPA processes from identification through effective closure.
• Provide quality oversight of production activities: process monitoring, in-process controls, and equipment calibration and maintenance.
• Support R&D, V&V, and manufacturing teams in maintaining quality throughout the product lifecycle.
• Oversee change control (ECR/ECO) and related product documentation.
• Prepare and maintain SOPs and the Design History File (DHF).

Requirements

• 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.
• High-level English (professional reading and writing).

Who You Are

• A natural owner, prior management experience isn’t required, but you’re professionally ready to lead and take full responsibility for the whole QA domain, not just execute within it.
• A fast learner, comfortable with ambiguity things move quickly here, and priorities shift as we grow.
• Reliable, steady, and independent, someone the whole company can lean on to run with the QA domain end-to-end.
• A strong communicator equally comfortable working with engineers, auditors, suppliers, and leadership.
• Hands-on and detail-oriented, without losing sight of the big picture.

Advantages

• Experience implementing QMS in start up or other rapidly changing environments.

Reports to: Head of RA/QA