Role Overview: Myant is a leading innovator in the field of textile-based technology, leveraging advanced materials and smart fabrics to enhance human health and wellness. With our cutting-edge developments in wearables, we aim to revolutionize how the world approaches personal care and health monitoring. We are looking for a passionate HR Manager to join our team and contribute to building a dynamic, collaborative, and innovative workplace culture. Senior Quality Assurance Specialist is a senior individual contributor responsible for strengthening and scaling Myant’s Quality Management System (QMS) within a regulated medical device environment, including Software as a Medical Device (SaMD) and software-enabled products. This role provides systems-level quality leadership, ensuring compliance with global regulatory standards (ISO 13485, MDSAP, EU MDR, and FDA QMSR), while driving risk-based decision-making, design control governance, and validation oversight. Acting as a key partner across Engineering, Operations, Regulatory Affairs, and Manufacturing, this role ensures quality and compliance are embedded across the full product lifecycle as the organization expands across North American and European markets. Key Responsibilities: Quality Management System (QMS) & Compliance Drive and maintain alignment of the QMS with ISO 13485, MDSAP, EU MDR, and FDA QMSR (21 CFR Part 820) requirements across multiple sites Monitor evolving regulatory requirements and lead gap assessments and implementation activities to maintain inspection readiness Exercise final quality review and approval authority for quality system documents, validations, investigations, and controlled records Risk Management Lead risk management activities in accordance with ISO 14971, including risk planning, hazard analysis, risk evaluation, control implementation, and residual risk assessment Ensure integration of risk outputs with complaints, CAPA, post-market surveillance, and design changes Design Control & Product Lifecycle Quality Own and govern design control processes for medical devices and SaMD products Lead design planning, design input/output definition, design reviews, verification and validation oversight, and design transfer Ensure completeness, traceability, and integrity of DHFs, DMRs, and DHRs Validation Governance Own enterprise validation strategy and governance, including process validation, software validation, equipment qualification, and product validation Ensure validation planning, protocol development, review, approval, and execution meet regulatory and quality requirements CAPA & Nonconformance Management Own the CAPA system, ensuring robust investigation practices, root cause analysis, implementation, effectiveness verification, and escalation of systemic issues Provide oversight of nonconforming product (NCR) processes, including investigation, disposition, trending, and linkage to CAPA Change Control Own quality decision-making within change control (ECR/ECN), including risk and validation impact assessments and final approvals Ensure all changes maintain compliance across design, process, and documentation Supplier Quality & External Partners Provide quality oversight for supplier qualification, approval, monitoring, and re‑evaluation in partnership with the QMS Administrator Support development and maintenance of quality agreements with suppliers, contract manufacturers, and service providers Audit & Inspection Readiness Own internal audit program strategy, including planning, scope, interpretation of findings, and follow‑up on corrective actions Support external audits including notified bodies, customers, FDA inspections, and MDSAP audits Lead preparation, response coordination, and closure of audit observations Quality Operations & Oversight Provide systems‑level oversight of production and process quality controls Own governance of the calibration program, ensuring compliance while execution is performed by QA Inspector Oversee management review inputs including KPIs, quality metrics, and trend analysis Post‑Market & Cross‑Functional Collaboration Partner with Regulatory Affairs on complaint trends, post‑market surveillance, and reportability assessments Ensure integration of post‑market data into CAPA, risk management, and design control processes Collaborate cross‑functionally with Engineering, Software, Operations, V&V, Program Management, and Manufacturing Leadership & Continuous Improvement Mentor QA Inspector and cross‑functional teams on quality systems, risk‑based thinking, and investigation rigor Drive continuous improvement initiatives across quality processes, focusing on scalability, standardization, and efficiency Required Qualifications Bachelor’s degree in Engineering (Biomedical, Mechanical, Electrical, Software, or related), Life Sciences, or a related technical field Minimum 7 years of progressive quality assurance experience in the medical device industry, including 3+ years in a senior or lead role Strong working knowledge of ISO 13485, ISO 14971, FDA QMSR (21 CFR Part 820), and EU MDR Experience with MDSAP audit requirements and multi‑market regulatory environments Proven experience leading design control activities for medical devices and/or SaMD Strong experience with CAPA systems, root cause analysis, and effectiveness verification Experience with validation governance (process, software, equipment) Demonstrated experience supporting or leading regulatory inspections and audits Strong communication skills with the ability to author and review technical and regulatory documentation Proven ability to collaborate cross‑functionally across technical and operational teams Preferred Qualifications Master’s degree in Engineering, Quality, Regulatory Science, or related field ASQ certifications (CQE, CQA) or equivalent ISO 13485 or MDSAP Lead Auditor certification Experience with Software as a Medical Device (SaMD) and IEC 62304 Experience supporting 510(k) submissions from a quality/design control perspective Familiarity with IEC 62366 (usability) and IEC 60601 (electrical safety) Experience in multi‑site or scaling quality systems Familiarity with eQMS platforms (e.g., Greenlight Guru, MasterControl, Veeva, ETQ) Experience with post‑market surveillance and field data integration into QMS processes Join us, and help build a healthier, more connected future. #J-18808-Ljbffr