Element Biosciences · 1 day ago
Senior Quality Engineer
San Diego, CA
Full-time
Onsite
Mid, Senior Level
$104K/yr - $137K/yr
5+ years expElement Biosciences is dedicated to empowering the scientific community and is looking for a Senior Quality Engineer to enhance their Quality Management System towards ISO 13485 compliance. This role involves providing quality engineering expertise for on-market products, leading continuous improvement projects, and collaborating with cross-functional teams.
BiotechnologyGeneticsHealth DiagnosticsLife Science
Responsibilities
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.)
Qualification
Required
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
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
Preferred
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
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
Benefits
Stock options
Discretionary annual bonus
No cost health insurance plans
401k with company match
Flexible paid time off
Company
Element Biosciences
Element Biosciences is a life science company that focuses on developing innovative genetic analysis tools.
201-500 employees
H1B Sponsorship
Element Biosciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (6)
2024 (4)
2023 (6)
2022 (8)
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
$678MKey Investors
Wellington ManagementVenrock
2024-07-11Series D· $277M
2021-06-29Series C· $276M
2020-06-26Series B· $30M
Leadership Team
Danae Van Oene
Senior Vice President, Global Sales and Support
Edwin Hauw
Senior Vice President, Marketing and Product Management
Recent News
2025-12-12
Company data provided by crunchbase