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 maturing Element’s Quality Management System (QMS) towards ISO 13485 compliance and provide quality engineering expertise on Element’s on-market products. This is an incredible opportunity for someone who is passionate about being a leader that can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with cross-functional teams. We are looking for candidates with a solid background in medical devices (Class I-II). Experience with developing strong working relationships with both internal and external customers to influence and enable an effective Quality Culture is a must. This role will report to the 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.

• →Spearhead development and continuous improvement of QMS processes, including but not limited to calibration and preventive maintenance program, design controls, process / design / software validation, management review etc
• →Interpret regulations and requirements to lead efforts related to Risk Management (FMEA), Verification & Validation, Design History File (DHF), Design Master Records (DMR), Device History Records (DHR)
• →Support activities related to audits, NCRs, complaints, change control and new product introductions, including problem resolution, guidance on effective CA/PA, improving documentation
• →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, Biology, or related science field (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 EU MDR, IEC 62304, 21CFR820, 21CFR 211 is strongly preferred
• Experience with wide range of validation including design, process, equipment, product and non-product software is strongly preferred
• Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
• Strong interpersonal skills with the ability to collaborate closely with suppliers and with internal stakeholders of varying levels to drive Quality System improvements
• Demonstrates an ability to work independently and as part of a team
• Self-motivated and able to organize and prioritize multiple tasks
• Strong inclination and passion for continuous improvement
• 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 (on-site)

• Domestic travel up to 10%

• Full-time/Exempt