Senior QA Lead, Life Sciences Compliance & Audit

Radiometer; United States; On-site; USD 104,000 - 181,000; Full time

Benefits offered by this job

Paid time off

Medical/dental/vision insurance

401(k)

Job summary

Integrated DNA Technologies (IDT) is seeking a Senior Quality Assurance Specialist to act as the primary on-site Quality representative for Sunnyvale, with support for San Diego. You will oversee the Quality Management System, ensure ISO 13485 compliance, and collaborate with Operations, Supply Chain, Engineering, Facilities, and R&D to embed quality across functions.

The role requires a technical degree and 5+ years in QA within life sciences, with travel up to 25% between sites.

Qualifications

• Bachelor's degree in a technical discipline.
• 5+ years of Quality Assurance experience in a regulated life sciences setting.
• Experience with ISO 13485, audits, and regulatory inspections.
• Knowledge of CAPA, nonconformance, change control, and risk management.

Responsibilities

• Serve as the primary on-site Quality representative for Sunnyvale operations and provide quality support for San Diego operations as needed.
• Maintain and support compliance with the IDT Quality Management System and ISO 13485.
• Partner with Operations, Supply Chain, Engineering, Facilities, and R&D teams across both sites to ensure quality requirements are implemented and sustained.
• Support internal and external audits, customer audits, supplier audits, regulatory inspections, and management reviews.
• Monitor site quality metrics and drive continuous improvement initiatives utilizing Danaher Business System tools and methodologies.
• Travel up to 25%, primarily between Sunnyvale and San Diego, with occasional domestic travel.

Skills

Quality Assurance

CAPA

Audits

Risk management

Change control

Education

Bachelor's degree in a technical discipline

Tools

ISO 13485

Job description

Integrated DNA Technologies (IDT) is seeking a Senior Quality Assurance Specialist to act as the primary on-site Quality representative for Sunnyvale, with support for San Diego. You will oversee the Quality Management System, ensure ISO 13485 compliance, and collaborate with Operations, Supply Chain, Engineering, Facilities, and R&D to embed quality across functions.

The role requires a technical degree and 5+ years in QA within life sciences, with travel up to 25% between sites.