Senior Quality Engineer

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.

We are seeking an experienced Senior Quality Engineer 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.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

• →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.
• →Lead / support activities related to audits, NCRs, complaints, change control and new product introductions, including problem resolution, guidance on effective CA/PA, improving documentation
• →Interpret regulations and requirements to support efforts related to Risk Management (FMEA), Design History File (DHF), Design Master Records (DMR), Device History Records (DHR).
• →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&D, Engineering, Mfg, Supply Chain, Commercial, Software etc.)

• Bachelors degree in Engineering or related technical discipline (an equivalent combination of experience and education may be considered)
• A minimum of 5 years’ experience, preferably in the medical device (Class I-II) or other regulated industry
• Experience with ISO13485 and ISO 14791 is required. Experience with IEC 62304 is strongly preferred.
• Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
• Strong collaboration skills and ability to drive decisions across multidisciplinary teams
• Self-motivated and able to organize and prioritize multiple tasks
• Strong analytical skills, reporting, and data analysis are strongly preferred
• Experience working with electronic Quality Management System and manufacturing-related business systems, like ERP and MES, is preferred
• ISO13485 Lead Auditor certification and ASQ CQE certification is a plus

• Frequently moves boxes weighing up to 20 pounds

• San Diego (onsite)

• Domestic travel up to 10%

• Full-time/Exempt