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 providing quality engineering expertise and support for Element’s on-market products, assessing and managing the Quality Management System (QMS) performance and improvement to ensure our processes and products are continuously meeting defined requirements. 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 life sciences. 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 Staff Quality Engineer 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:
- Supports all aspects of Quality System for on-market products, including Non-Conformance Reports, Corrective and Preventative Actions, Complaint Investigations, Change Management, Risk Assessments, and support of internal and/or external audits
- Provides quality support on internal failure investigations and leads / facilitates supplier investigations, ensuring corrective and preventive actions are effective and implemented in a timely manner
- Provides quality input on internal and external test method / component / equipment qualifications, including review of test plans / protocols and reports, guidance on inspection requirements and sampling plans, and risk assessments
- Establish effective Quality Procedures associated to the Quality Management System
- Responsible for establishing and continuous improvement of Quality Systems processes through collection of customer feedback, establishment of metrics, data trending
- Provides Quality Engineering expertise, guidance, coaching for Manufacturing Operations, Supplier Quality, Product Quality, and New Product Development as needed
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 5 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 continuous improvement
- 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:
Travel:
- Domestic travel up to 10%
Job Type:
Base Compensation Pay Range:
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.
