Senior QA Specialist - On-Site Life Sciences Quality Leader

Integrated DNA Technologies; Sunnyvale (CA); In loco; USD 104.000 - 181.000; Tempo pieno

Vantaggi offerti da questo lavoro

Health insurance

Dental insurance

Vision insurance

401(k)

Paid time off

Descrizione del lavoro

Integrated DNA Technologies (IDT) in Sunnyvale, CA, is seeking an on-site Senior Quality Assurance Specialist to provide primary regional QA oversight and support the San Diego facility as needed. The role ensures regulatory compliance, quality system integrity, and collaboration with cross-functional teams.

The position emphasizes ISO 13485 compliance, CAPA and change control, audits, and continuous improvement across sites, with up to 25% travel.

Competenze

• Bachelor's degree in a technical discipline.
• 5+ years of Quality Assurance experience in a regulated life sciences 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.

Mansioni

• 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.

Descrizione del lavoro

Integrated DNA Technologies (IDT) in Sunnyvale, CA, is seeking an on-site Senior Quality Assurance Specialist to provide primary regional QA oversight and support the San Diego facility as needed. The role ensures regulatory compliance, quality system integrity, and collaboration with cross-functional teams.

The position emphasizes ISO 13485 compliance, CAPA and change control, audits, and continuous improvement across sites, with up to 25% travel.