Quality Assurance Manager

col-wideJob Description:

Join a visionary team at the cutting edge of biosensor technology, transforming clinical diagnostics. Our client, an innovative deep tech organization, is dedicated to enhancing and accelerating diagnostic services in healthcare settings.
It's an opportunity to be part of a mission that significantly impacts the lives of patients and the efficiency of hospitals. For those driven to make a real difference in health and wellbeing, this role offers the chance to contribute to groundbreaking advancements that will shape the future of medical diagnostics and patient outcomes.
Role
A committed QA Manager to guide the creation and implementation of a QMS that meets international criteria. This role is critical in assuring that products are developed and produced to the highest standards, and you'll be central to the strategy for achieving market approval globally.
Responsibilities
Establishing and enforcing a robust QMS in line with ISO 13485 and 9001 for IVD products.
Steering the product approval process, ensuring cross-departmental collaboration.
Building lasting relationships with external QA entities, including regulators and inspectors.
Developing policies that reflect our commitment to unmatched quality.
Launching SOPs and conducting thorough internal audits to assure process integrity.
Fostering a workplace ethos of quality and excellence.
Working with executives to pinpoint crucial QA success metrics.

Qualifications
Bachelor's degree or equivalent experience in Engineering, life science or related healthcare
5+ years' relevant work QA experience in IVD

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