Senior Quality Engineer

<div class="content-intro"><p>Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow™ Wearable Breast Pump, selected as one of TIME's 25 Best Inventions in 2017 and 2018 CES Innovation Award for Wearable Technologies, is the first solution in our platform.</p></div><p><strong>Job Overview:</strong></p> <p><em>The Senior Quality Engineer will participate in the implementation and maintenance of QSR (21 CFR 820) and ISO 13485: 2016 quality systems and qualification activities of Willow Innovations medical breast pump products and non-medical consumer products in support of the Company’s development, manufacturing, quality, regulatory, and clinical affairs efforts. In addition, this position will support the development and implementation of quality systems, quality/reliability engineering disciplines, and </em><em>compliance activities.</em></p> <p>&nbsp;</p> <p><strong>Roles &amp; Responsibilities | What you'll do:</strong></p> <h4>1. Drive Design Assurance in Product Development</h4> <ul> <li>Ensure compliance with design control requirements (ISO 13485, FDA 21 CFR Part 820, EU MDR, and Health Canada regulations) throughout the product lifecycle.</li> <li>Partner with R&amp;D and cross-functional teams to implement risk-based approaches to product design.</li> <li>Develop and maintain Design History Files (DHF) to support regulatory submissions and audits.</li> </ul> <h4>2. Conduct Risk Management Activities</h4> <ul> <li>Lead Failure Modes and Effects Analysis (FMEA) for design, process, and usability risks.</li> <li>Ensure compliance with ISO 14971 risk management requirements.</li> <li>Facilitate risk assessments and collaborate with cross-functional teams to mitigate potential hazards.</li> </ul> <h4>3. Develop and Execute Verification &amp; Validation (V&amp;V) Plans</h4> <ul> <li>Define test strategies, acceptance criteria, and protocols for design verification and validation.</li> <li>Review and approve test reports and data analysis to ensure compliance with regulatory standards.</li> <li>Maintain traceability from user needs to design inputs, outputs, and validation results.</li> </ul> <h4>4. Ensure Compliance with Regulatory &amp; Quality Standards</h4> <ul> <li>Support internal and external audits related to design assurance and regulatory compliance.</li> <li>Ensure documentation aligns with FDA QMSR, EU MDR, ISO 13485, IEC 62304 (Software),&nbsp; IEC 60601 (Safety), IEC 62366 (Usability),Health C