Our 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:
- Facilitate Change Management process as a member of the Change Control Board.
- Leads and facilitates failure investigations, if needed, ensuring mitigations and corrective actions are implemented in a timely manner.
- Establish effective Quality Procedures associated to the Quality Management System.
- Monitor Quality systems processes through Product Quality Review and Management Review.
- Responsible for continuous improvement of Quality Systems processes through collection of customer feedback and data trending.
- Plan and perform third-party audits and internal audits, as needed.
- Supports incoming inspection, Quality Control, and quality release of all products.
- Provides Quality Assurance expertise, guidance, coaching for New Product Development, Manufacturing Operations, Supplier Development, and Product Quality.
- Participation in the following QMS Systems: Complaint Investigations, Corrective and Preventative Actions, Non-Conforming Material Reports, Internal Audits, Change Management, Risk Assessments, and support of client audits.
- Other duties as assigned.
- Experience with ISO9001, ISO13485, 21CFR820, 21CFR 211, or other regulated industries is strongly preferred.
- Experience with Computer Systems Validation and electronic Quality Management System strongly preferred
- Ability to understand quality systems and implement systemic changes to enhance product quality and business efficiency.
- Strong interpersonal skills with the ability to collaborate closely with 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 strong preferred.
- Experience with manufacturing-related business systems, like ERP and MES, is preferred.
- Ability to work in a fast-paced and technically challenging environment where drive is critical to success.
- ISO13485 Lead Auditor certification a plus
- ASQ CQA certification a plus
EDUCATION AND EXPERIENCE:
- S./B.A. degree in Engineering, Biology, Molecular Biology, Microbiology, or related science field (an equivalent combination of experience and education may be considered).
- A minimum of 4 years’ experience, preferably in the life sciences industry.
- Must be able to lift 15 pounds.
- Domestic and international travel up to 15%
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.