Senior Supplier 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.

The Senior Supplier Quality Engineer is responsible for developing and maintaining a framework to continuously assess and manage supplier risks, and improvements to ensure consistency in supplier performance and parts quality. The incumbent must be a leader who can work with significant autonomy and independent judgement to achieve our Quality goals and lead continuous improvement projects with our critical/strategic suppliers. You will need to have the interpersonal skills to develop strong working relationships with both internal customers and our critical/strategic suppliers to enable more effective supplier management and improvement of supplier performance.

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:

• Participate in and/or lead the identification, selection, qualification, monitoring, and disengagement of product, service, and contract manufacturing suppliers.
• Support and Manage supplier qualification process and Quality Agreements.
• Plan and perform supplier and third-party audits, as necessary.
• Lead the issuance of supplier nonconformances (SCARs) and the verification of corrective action effectiveness.
• Leads and facilitates failure investigations, if needed, ensuring mitigations and corrective actions are implemented in a timely manner.
• Ensure raw material specifications are aligned with receiving inspection requirements.
• Support the management of the Approved Supplier List and supplier files.
• Performs supplier monitoring by providing performance metrics.
• Participation in the following QMS Systems: Customer 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.

REQUIRED SKILLS/ABILITIES:

• Experience with ISO9001, ISO13485, 21CFR820, 21CFR 211, or other regulated industries is strongly preferred.
• Experience issuing and reviewing supplier non-conformances (SCARs).
• Experience performing supplier audits and supporting supplier qualifications.
• Strong interpersonal skills with the ability to collaborate closely with Operations and R&D staff to drive Quality System improvements and meet 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 preferred.
• Experience with manufacturing-related business systems, like ERP and MES, is preferred.
• Current certifications from recognized Quality organizations (e.g., ASQ) for Quality Engineering and/or Quality Auditing is strongly preferred.

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 5 years’ experience, preferably in the life sciences industry, with at least 2 years’ direct experience in professional Quality role(s).

PHYSICAL REQUIREMENTS:

• Must be able to lift 15 pounds.

TRAVEL:

• Domestic and international travel up to 30%

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.