Chief operation officer - medical device scale-up

Our team is looking for a highly skilled Senior Quality Engineer to play a pivotal role in the commercialization of our novel product. This is an exciting opportunity to make a real impact and drive quality, efficiency, and global regulatory compliance from the ground up.


Job Description

We are seeking an autonomous and experienced Senior Quality Engineer with deep expertise in Operations Quality and New Product Introduction (NPI). This role requires a 'quality-first' mindset and a proven ability to manage complex compliance requirements across multiple external vendors.

* Serve as the core Quality contact, assessing and ensuring manufacturing contractor's processes meet all quality controls.
* Ensure comprehensive compliance with FDA QSR (21 CFR Part 820), ISO 13485, EU MDR, and ISO 14971 (Risk Management) as the product is commercialized globally.


Key Responsibilities:

1. Contract Manufacturer Oversight: Assess and ensure manufacturing contractor's processes meet all quality controls.