Senior QA Specialist - Life Sciences Compliance & Audits

Danaher Corporation; Sunnyvale (CA); On-site; USD 104,000 - 181,000; Full time

Benefits offered by this job

Bonus eligible

Benefits package including health, 401

Paid time off

Job summary

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Senior Quality Assurance Specialist to lead on-site quality for Sunnyvale with support for San Diego. You will maintain the Quality Management System, drive regulatory compliance, and collaborate with multi-functional teams to ensure robust QA processes.

The role emphasizes audits, CAPA, and risk management, with travel up to 25% between Sunnyvale and San Diego.

Qualifications

• Bachelor’s degree in a technical discipline.
• 5+ years of Quality Assurance experience in a regulated life sciences, diagnostics, medical device, or biotechnology environment.
• Demonstrated expertise with ISO 13485 Quality Management Systems.
• Experience supporting audits and regulatory inspections.
• Working knowledge of CAPA, nonconformance, change control, and risk management processes.

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 applicable regulatory requirements, including ISO 13485.
• Partner with Operations, Supply Chain, Engineering, Facilities, and R&D teams across both sites to ensure quality requirements are effectively 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.

Skills

Quality Assurance

Audits

Regulatory compliance

CAPA

Change control

Risk management

Education

Bachelor’s degree in a technical discipline

Tools

ISO 13485 knowledge

CAPA tooling

Change control

Risk management processes

Job description

Integrated DNA Technologies (IDT), a Danaher operating company, seeks a Senior Quality Assurance Specialist to lead on-site quality for Sunnyvale with support for San Diego. You will maintain the Quality Management System, drive regulatory compliance, and collaborate with multi-functional teams to ensure robust QA processes.

The role emphasizes audits, CAPA, and risk management, with travel up to 25% between Sunnyvale and San Diego.