Senior Manufacturing QA Role
We are seeking an experienced Senior Manufacturing Quality Assurance professional to support the commercial manufacturing of our cutting-edge connected health solution for chronic wound care.
Main Responsibilities:
* Ensure quality oversight for electronics/system-level manufacturing with contract manufacturers
* Lead investigations and corrective actions for non-conformances
* Support validation 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 a related discipline
* At least 3-7 years of experience in QA or manufacturing quality within a regulated industry
* Strong knowledge of ISO 13485, FDA QSR, and process validation principles
* Experience supporting regulatory audits or working with Regulatory Affairs teams
Preferred Skills:
* Contract manufacturing experience
* Certifications in CQE, Six Sigma, or auditing