Staff Design 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 Staff Design Quality Engineer who will play a pivotal role in providing quality engineering expertise in support of Element’s new product introductions.  You will be working with engineering, chemistry, and software R&D teams to develop groundbreaking new products and strengthen Element’s Quality Management System (QMS). 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 our design quality efforts with cross-functional teams. We are looking for candidates with a solid background in life sciences. Experience with developing strong working relationships with teams across Element to influence and enable an effective Quality Culture is a must. This role will report to the Director of Quality and Regulatory 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.

Essential Functions and Responsibilities:

• Owns all aspects of Design Quality for NPI including risk management, design controls, and design history file
• Provides support for project planning, requirements/specifications development, design verification and validation, design transfer, process development, process validation, risk management, and/or human factors
• Drive quality mentality and proactive measures as a Quality representative on NPI core teams
• Drive cross functional engagement of Design Quality with company leadership
• Owns risk management activities for new product introductions
• Resolve complex issues using professional Quality Management concepts
• Establish effective Quality Procedures associated with the Quality Management System
• Lead Quality driven projects such as qualification of sites and manufacturing lines
• Work with NPI sourcing to ensure supplier suitability
• Supports audits to ensure the quality and completeness of product Design History Files and/or Device Master Record
• Drive and own system documenting product requirements, design inputs, design outputs, and verification
• Provides understanding of quality and statistical analysis tools (e.g. SPC, Six Sigma, Risk Analysis, FMEA, DOE, statistical comparison tests, and trend analysis)

Education and Experience:

• Bachelors degree in Engineering, Biology, Molecular Biology, Microbiology, or related science field (an equivalent combination of experience and education may be considered)
• A minimum of 10 years’ experience, preferably in the life sciences industry or fast pace start up
• Experience with ISO9001, ISO13485, 21CFR820, 21CFR 211, or other regulated industries is strongly preferred
• Ability to understand quality systems and implement risk-based, systemic changes to enhance product quality and business efficiency in a scalable manner
• Strong interpersonal skills with the ability to collaborate closely with suppliers and with internal Production and Operations staff of varying levels to drive Quality System improvements and deliver necessary compliance requirements
• 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 design quality
• Strong analytical skills, reporting, and data analysis are strongly preferred
• Ability to work in a fast-paced and technically challenging environment where adaptability and drive are critical to success
• Experience 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

Physical Requirements:

• Frequently moves boxes weighing up to 20 pounds

Location:

• San Diego

Travel: 

• Domestic travel up to 10%

Job Type:

• Full-time/Exempt

Base Compensation Pay Range:

• $125,000 - $165,000

In addition to base compensation noted above, you will be eligible for stock options, discretionary annual bonus, no cost health insurance plans, 401k with company match, and flexible paid time off. 

Please note: Base compensation will depend on multiple factors, including geographic location, qualifications, and experience. 

We foster an environment such that all people are afforded the freedom to pursue their passions without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.