Sr Quality Engineer
Element Biosciences is a multi-disciplinary startup focused on innovating genetic analysis tools for the research and clinical markets. The Company's technology will broaden the end user experience through improved data quality and simplified workflows to benefit discoveries and diagnosis in healthcare.
Our Sr. Quality Engineer is responsible to assess and manage the Quality Management System (QMS), performance and improvement to ensure our processes are continuously meeting defined requirements. You must be 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. You will need to have the interpersonal skills to develop strong working relationships with both internal and external customers to influence and enable an effective Quality Culture.
We are building a fully integrated Operations team to work closely with our technology and product development teams to empower the scientific community and accelerate our collective impact on humanity. We are looking for self-motivated candidates that are excited by a startup environment where opportunity to rise to frequent and diverse challenges is commonly encountered.
ESSENTIAL FUNCTIONS AND RESPONSIBILITIES:
- Lead and support component and product failure investigations, ensuring mitigations and corrective actions are implemented in a timely manner.
- Manage the Supplier Corrective Action Request (SCAR) and other supplier quality related issues, including track and trending of defects.
- Support the Change Management process as it applies to design changes and process changes.
- Maintain effective Quality Procedures associated to the Quality Management System.
- Monitor Quality systems processes through KPIs and Management Review.
- Responsible for continuous improvement of Quality Systems processes through collection of customer feedback and data trending.
- Supports incoming inspection, Quality Control, and quality release of products.
- Provides Quality Systems guidance and training.
- Responsible for Quality Systems development and maintenance: Complaints, NCR, CAPA, Change Control, Risk Management, and Audits.
- Plan and perform third-party audits and internal audits, as needed.
- Other duties as assigned.
- Experience with ISO9001, ISO13485, 21CFR820, 21CFR 211, or other regulated industries is strongly preferred.
- Experience with using Root Cause Analysis methods and tools (i.e., 8D, 5Whys, Ishikawa, Is/Is Not, etc.).
- Experience with electronic Quality Management System strongly preferred.
- Experience with pFMEA development and using risk management tools.
- Experience with Design Control is a strong plus.
- Well versed in quality systems processes and keen on continuous improvement to support the production process and improve business efficiency.
- Strong interpersonal skills and ability to collaborate closely with R&D and Operations staff to drive Quality System utilization and meeting necessary business and compliance requirements.
- Demonstrates an ability to work independently and as part of a team.
- Self-motivated and able to organize and prioritize multiple tasks.
- Experience with manufacturing-related business systems, like ERP and MES, is preferred.
- Strong analytical skills, reporting, and data analysis are strong preferred.
- ISO13485 Lead Auditor certification is a strong plus.
- Ability to work in a fast-paced and technically challenging environment where drive is critical to success.
- ASQ CQA certification a plus
EDUCATION AND EXPERIENCE:
- S./B.A. degree in Engineering, scientific discipline, or equivalent combination of experience and education may be considered.
- A minimum of 5 years of experience, preferably in the life sciences industry.
- Must be able to lift 15 pounds.
- Domestic and international travel up to 15%
BASE COMPENSATION PAY RANGE: $97,200 - $108,000
In addition to base compensation, 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 are passionate about our mission to develop high performing products to study genomics in unprecedented flexibility and to understand biology for the improvement of healthcare. 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 offer excellent benefits, which include a 401K plan, competitive health benefits, flexible vacation, and equity incentives.
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.