Senior Quality Assurance Leader — ISO 9001 & CAPA Expert

Socket.dev; Illinois; On-site; USD 110,000 - 140,000; Full time

Job summary

Socket.dev is seeking a Quality Assurance Manager to lead the development, implementation, and maintenance of quality management systems to meet regulatory and customer standards.

The role drives continuous improvement through CAPA and RCA, oversees supplier quality and audits, and partners with production, regulatory, and development teams to ensure safe, reliable, high‑quality products and ongoing ISO9001 compliance.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or related field.
• Minimum 5 years of QA in regulated industry (medical devices/pharma).
• ISO9001 quality systems management experience; CAPA and RCA.
• Experience with supplier quality and supplier audits.

Responsibilities

• Develop, implement, and maintain quality management systems in ISO9001 and other standards.
• Lead investigations and root cause analysis for quality issues; drive CAPA actions.
• Manage supplier quality assurance activities, including audits and monitoring.
• Collaborate with cross-functional teams to integrate quality into product development and manufacturing.
• Monitor quality metrics and prepare reports for senior management.
• Ensure regulatory compliance and prepare documentation for audits.
• Train and mentor QA staff to promote continuous improvement.

Skills

CAPA

ISO 9001

Supplier quality

Root cause analysis

Audits

Cross-functional

Education

Bachelor’s degree in Engineering, Life Sciences, or related field

Tools

Quality management software

Data analysis tools

Job description

Socket.dev is seeking a Quality Assurance Manager to lead the development, implementation, and maintenance of quality management systems to meet regulatory and customer standards.

The role drives continuous improvement through CAPA and RCA, oversees supplier quality and audits, and partners with production, regulatory, and development teams to ensure safe, reliable, high‑quality products and ongoing ISO9001 compliance.