Senior Quality Specialist
This role is pivotal in ensuring the company's quality systems are robust, scalable, and aligned with regulatory requirements.
The ideal candidate will have a proven track record of maintaining and evolving quality management systems to support internal manufacturing and external supply chain operations.
* Maintain and evolve the QMS in compliance with ISO 13485, FDA 21 CFR 820, and other applicable regulations.
* Oversee all quality aspects of internal manufacturing operations, including batch release, in-process controls, and product inspections.
* Provide quality oversight for subcontract manufacturing partners, including audits, quality agreements, and supplier performance management.
* Lead internal and external audits, manage CAPAs, and ensure continuous improvement across all quality processes.
* Support internal R&D, engineering, and operations teams with quality input during project development and tech transfer.
* Act as the quality lead for product lifecycle activities from development through commercialization.
About You
* 5+ years' experience in quality assurance within the medical device industry, ideally with Class II/III devices.
* Strong working knowledge of ISO 13485, FDA QSR, MDR, and relevant global regulatory frameworks.
* Experience with both internal and contract manufacturing environments.
* Demonstrated ability to build, maintain, and improve quality systems in a fast-paced setting.
* Practical, solution-oriented approach with excellent communication and collaboration skills.
* Degree in Engineering, Science, or a related technical field.
What We Offer
* A dynamic and collaborative environment where your expertise directly influences business growth.
* A competitive salary, benefits, and equity participation package.
* Opportunity to shape and lead the quality function during a critical phase of expansion.