Senior Quality Engineer

<p></p> <p>At Element Biosciences, we are passionate about our mission to empower the scientific community with more freedom and flexibility to accelerate our collective impact on humanity. We have built a highly efficient product-driven organization where employees can learn, grow, and thrive in a challenging but encouraging environment. We are committed to scientific integrity, collegiality, honesty, objectivity, and openness.</p> <p>We are seeking an experienced&nbsp;<strong>Senior Quality Engineer</strong> who will play a pivotal role in supporting the ongoing maturation of our Quality Management System (QMS) and providing QE expertise on Element’s on-market products. This role is ideal for someone who is passionate about continuous improvement and cross-functional collaboration to achieve greater outcomes. We are looking for candidates with a solid QE background in medical devices (Class I-II). Experience with developing strong working relationships with teams to maintain our quality culture is a must. This role will report to the Senior Manager, Quality Engineering and will be a San Diego based role.</p> <p>If you possess the following and want to make a meaningful impact, we invite you to explore this role.</p> <p><strong>Essential Functions and Responsibilities:</strong></p> <ul> <li>Collaborate with cross-functional teams to gather feedback and lead / support continuous improvement of QMS processes, including but not limited to supplier controls, equipment onboarding/qualification, process / design verification and validation, CSV, etc.</li> <li>Lead / support activities related to audits, NCRs, complaints, change control and new product introductions, including problem resolution, guidance on effective CA/PA, improving documentation</li> <li>Interpret regulations and requirements to support efforts related to Risk Management (FMEA), Design History File (DHF), Design Master Records (DMR), Device History Records (DHR).</li> <li>Provide quality engineering expertise throughout all product lifecycles, from design and development to post-market surveillance, requiring solid understanding of the company’s product portfolio and close collaboration with multiple functions (R&amp;D, Engineering, Mfg, Supply Chain, Commercial, Software etc.)</li> </ul> <p><strong>Education and Experience:</strong></p> <ul> <li>Bachelors degree in Engineering or related technical discipline (an equivalent combination of experience and education may be considered)</li> <li>A minimum of 5 years’ experience, preferably in the medical device (Class I-II) or other regulated industry</li> <li>Experience with ISO13485 and ISO 14791 is required. Experience with IEC 62304 is strongly preferred.</li> <li>Ability to work in a fast-paced and technically ch