Director, Quality

Element Biosciences; San Diego (CA); On-site; USD 152,000 - 215,000; Full time

Benefits offered by this job

Stock options

Discretionary annual bonus

No-cost health insurance plans

401k with company match

Flexible paid time off

Job summary

Element Biosciences is seeking an experienced Director of Quality to lead our Quality function and advance the maturity of our QMS across research-use and regulated products. This role reports to the Chief Supply Chain Officer and serves as the senior Quality authority for ISO 13485, with responsibility for Quality Systems, Quality Engineering, Supplier Quality, and more.

The Director will collaborate with Product Development, Manufacturing, Supply Chain, Regulatory Affairs, and others to ensure

Qualifications

• Bachelor's degree in engineering, life sciences, chemistry, or a related technical discipline.
• Typically 15+ years of progressively responsible Quality experience within medical devices or regulated products.
• Experience leading ISO 13485 quality systems and regulatory inspections.

Responsibilities

• Lead Element's Quality function and QMS, establishing strategy, policies, objectives, metrics, and priorities.
• Serve as Management Representative for ISO 13485 QMS and report performance to executives.
• Provide independent judgment on product, process, supplier, and quality system risks and lead CAPA and change control.
• Oversee lifecycle quality, including design controls, risk management, validation, and product release.
• Own Supplier Quality, including supplier audits and corrective actions.
• Lead inspection/readiness for FDA, ISO, and external audits; resolve findings.
• Partner with Regulatory Affairs on lifecycle activities and regulatory implications.
• Build a high-performing Quality organization with clear accountability and scalable processes.

Skills

Quality leadership

ISO 13485

Regulatory audits

CAPA

QMS management

Risk management

Cross-functional

Project management

Auditing

SaMD

Education

Bachelor's degree in engineering, life sciences, chemistry, or related technical discipline

Job description

At Element Biosciences, we are passionate about our mission to develop high performing products to study genomics with unprecedented flexibility and quality that enable researchers to better understand biology for the improvement of global health. 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 Director of Quality to lead Element Biosciences' Quality function and ensure the continued effectiveness, scalability, and maturity of our Quality Management System (QMS) as the company expands its research-use and regulated product portfolio.

Reporting directly to the Chief Supply Chain Officer, the Director of Quality will serve as Element's senior Quality leader, independent Quality authority, and Management Representative for the company's ISO 13485 Quality Management System. This role will have responsibility for Quality Systems, Quality Engineering, Supplier Quality, Quality Control and incoming inspection, Document Control, audit and inspection readiness, and product and process quality.

The Director will build upon Element's existing quality system foundation and partner closely with Product Development, Manufacturing, Supply Chain, Service, Regulatory Affairs, Clinical, and other functions to ensure that products and processes meet applicable quality requirements throughout the product lifecycle. The Director will promote a culture in which quality requirements are incorporated early, risks are identified and addressed proactively, and quality systems enable both compliance and efficient execution.

If you possess the following and want to make a meaningful impact, we invite you to explore this role.

Essential Functions and Responsibilities:

• Lead Element's Quality function and QMS, establishing Quality strategy, policies, objectives, metrics, and priorities and ensuring continued compliance with applicable quality system regulations, standards, company policies, and procedures
• Serve as Management Representative for the ISO 13485 QMS, ensuring required QMS processes are established and maintained, reporting QMS performance and improvement needs to executive management, and promoting awareness of applicable quality and regulatory requirements throughout the organization
• Serve as the company's senior Quality authority, providing independent judgment and escalation on significant product, process, supplier, and quality system risks and leading Management Review, CAPA, nonconformance, complaint, change control, document control, and continuous improvement processes
• Lead product and process quality throughout the lifecycle, including design controls, risk management, verification and validation, new product development, design transfer, manufacturing readiness, sustaining changes, incoming/in-process/final quality controls, and product release
• Own Supplier Quality, including supplier qualification and monitoring, risk classification, quality agreements, supplier audits, corrective actions, and escalation of significant supplier related risks
• Lead organizational inspection and audit readiness, including FDA inspections, ISO certification and surveillance audits, notified body QMS audits, customer audits, and other Quality-related assessments, and ensure timely and effective resolution of findings
• Partner with Regulatory Affairs on regulated product lifecycle and post-market activities, with Quality responsible for investigation, root cause analysis, quality risk assessment, containment, and corrective action, and Regulatory Affairs responsible for regulatory impact assessments, reporting, notifications, and market authorization implications
• Build and develop a high performing Quality organization, establishing clear accountability, decision rights, scalable processes, and a culture of proactive risk management, constructive challenge, continuous improvement, and cross-functional partnership

Education and Experience:

• Bachelor's degree in engineering, life sciences, chemistry, or a related technical discipline; advanced degree preferred
• Typically 15+ years of progressively responsible Quality experience within medical devices, IVDs, life science tools, or similarly regulated products, including significant leadership responsibility
• Demonstrated experience leading and scaling Quality organizations and ISO 13485 Quality Management Systems, including experience serving as or working closely with a Management Representative
• Deep working knowledge of ISO 13485, FDA quality system requirements, ISO 14971, design controls, CAPA, complaint handling, change control, supplier quality, validation, and auditing principles
• Demonstrated experience leading regulatory inspections, ISO/notified body audits, and other external Quality audits, including management of findings and corrective actions
• Strong experience supporting product development, design transfer, manufacturing, and commercial product lifecycle processes; experience with complex instrumentation, IVD, NGS, software enabled products, or SaMD preferred
• Strong risk-based judgment, executive communication skills, and demonstrated ability to influence technical and business leaders while maintaining appropriate Quality independence and authority
• Self-directed, pragmatic, collaborative, and comfortable operating in a fast-paced environment with evolving priorities; demonstrated commitment to developing people and organizational capability
• ASQ certifications such as CQE, CQA, or CMQ/OE are preferred

Physical Requirements:

• Must be able to lift up to 15 pounds.

Travel:

• Willingness to travel up to approximately 10% of the time

Job Type:

• Full-time, Exempt

Base Compensation Pay Range:

• $152,000 - $215,000

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.

We do not discriminate on the basis of any protected group status under any applicable law.

As set forth in Element Biosciences’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.