Director, Quality Systems & Compliance

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

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