7 дней назад
Senior Quality Assurance Specialist
103 500 - 181 000$
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Quality Assurance Specialist (ISO 13485/biotechnology): Overseeing quality management systems and regulatory compliance for IDT's Sunnyvale operations, with quality support for the San Diego facility and an accent on audits, CAPA, change control, and risk management. Focus on partnering across operations and technical teams, driving continuous improvement with Danaher Business System methods, and maintaining compliance across multiple California sites.
Location: On-site in Sunnyvale, California, United States, with periodic support and travel to San Diego
Annual salary: $103,500–$181,000 USD, plus eligibility for bonus or incentive pay.
Company
operates Integrated DNA Technologies (IDT), a life sciences and genomics organization supporting research and biotechnology advances.
What you will do
- Serve as the primary on-site Quality representative for the Sunnyvale operation and support the San Diego facility as needed.
- Maintain the IDT Quality Management System and compliance with applicable regulatory requirements, including ISO 13485.
- Partner with Operations, Supply Chain, Engineering, Facilities, and R&D teams across both sites.
- Support internal, external, customer, and supplier audits, regulatory inspections, and management reviews.
- Monitor site quality metrics and drive continuous improvement using Business System tools and methodologies.
Requirements
- 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.
- Ability to travel up to 25%, primarily between Sunnyvale and San Diego, with occasional domestic travel.
Culture & Benefits
- Collaborative environment focused on scientific excellence, continuous learning, and continuous improvement.
- Paid time off and medical, dental, and vision insurance for eligible employees.
- 401(k) benefits for eligible employees.
- Opportunity to contribute to life sciences, diagnostics, biotechnology, and genomics programs.
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