Senior Quality Assurance Professional
Our innovative medical device company seeks a quality assurance expert to support commercial manufacturing of a connected health solution for chronic wound care.
This role is ideal for a professional with experience in manufacturing, supplier oversight, and regulatory compliance.
* Oversee quality for electronics/system-level manufacturing with contract manufacturers.
* Lead investigations and CAPA for non-conformances.
* Support IQ/OQ/PQ validations and documentation reviews.
* Monitor supplier quality and contribute to audit preparedness.
* Collaborate on regulatory submissions and inspection readiness.
Key Requirements:
* Degree in Engineering, Quality, or related discipline.
* 3-7 years in QA or manufacturing quality within a regulated industry.
* Strong knowledge of ISO 13485, FDA QSR, and process validation.
* Experience supporting regulatory audits or working with Regulatory Affairs teams.
* Advantageous: Contract manufacturing experience, CQE, Six Sigma, or auditing certifications.
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About the Opportunity
This is an exciting opportunity to leverage your expertise in quality assurance and make a meaningful impact in the development of innovative medical devices.
As a key member of our team, you will have the chance to work collaboratively with cross-functional groups to drive quality initiatives and ensure the delivery of high-quality products.
Join us in our mission to revolutionize healthcare by bringing cutting-edge solutions to market!