Quality System Manager

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    "description": "<p><span style=\"font-weight: bold;\">Quality System Manager</span><br>Location: Remote (Europe-based preferred)<br>Type: Full-time<br>Industry: Digital Health, SaMD, DTx<br>Reports to: Head of Compliance</p>\n<p><br><span style=\"font-weight: bold;\">Position Overview</span><br>We are seeking a Quality System Manager to strengthen our ISO 13485-compliant Quality Management System. You will support internal audits, CAPAs, supplier evaluations, and documentation processes that underpin our medical-grade digital therapeutics. This role is key to our ability to maintain compliance while scaling agile and user-centered innovation across multiple therapeutic areas.</p>\n<p><br><span style=\"font-weight: bold;\">Key Responsibilities</span></p>\n<ul>\n<li>Maintain and improve our QMS in alignment with ISO 13485, MDR, and applicable FDA regulations.<br></li>\n<li>Support internal and supplier audits, prepare documentation, and lead follow-up activities.<br></li>\n<li>Manage CAPAs, nonconformities, and change control documentation.<br></li>\n<li>Provide QA oversight to product development activities, including design controls and verification/validation protocols.<br></li>\n<li>Train internal teams on quality procedures and support audit readiness across functions.</li>\n</ul>\n<p><br><span style=\"font-weight: bold;\">Required Qualifications</span></p>\n<ul>\n<li>3+ years of quality assurance experience in medical devices or health tech.<br></li>\n<li>Solid understanding of ISO 13485, ISO 14971, IEC 62304, IEC 62366 and MDR compliance.<br></li>\n<li>Strong documentation and organizational skills.<br></li>\n<li>Excellent English communication skills.</li>\n</ul>\n<p><br></p>\n<p><span style=\"font-weight: bold;\">Why Join Newel Health</span></p>\n<ul>\n<li>Shape the next generation of digital health solutions.</li>\n<li>Work in a certified SaMD environment at the forefront of behavioral science and AI.<br></li>\n<li>Collaborate with leading partners in Pharma, MedTech, and academic research.<br></li>\n<li>Enjoy a remote-first culture, supported by cross-disciplinary teams passionate about patient outcomes.<br></li>\n<li>Be part of an organization building scalable, evidence-based impact in chronic care management.<br></li>\n</ul>",
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