19 часов назад
Quality Assurance Compliance Specialist I (Medical Devices)
60 000 - 70 000$
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Assurance Compliance Specialist I (Medical Devices): Supporting quality management system compliance for medical devices and software with an accent on CAPA activities, audits, regulatory documentation, and global medical device requirements. Focus on maintaining QMS records, verifying audit and CAPA effectiveness, managing UDI data, and supporting FDA, ISO 13485, EUMDR, and MDSAP compliance.
Location: Chelmsford, Massachusetts, United States
Annual salary: $60,000–$70,000
Company
develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions, serving healthcare, emergency services, public safety, and military customers worldwide.
What you will do
- Support maintenance of the Quality Management System in line with FDA 21 CFR Part 820, ISO 13485, EUMDR, and global regulatory requirements.
- Assist with CAPA initiation, investigation support, tracking, and effectiveness verification.
- Participate in internal audits and support FDA, Notified Body, and MDSAP inspections and audit-readiness activities.
- Track, investigate, and close audit nonconformities.
- Maintain quality documentation according to Good Documentation Practices.
- Support UDI data generation and maintenance, product regulatory documentation, and QMS training compliance.
Requirements
- Bachelor’s degree in Engineering, Life Sciences, or a related technical field preferred; an associate degree or technical certification with relevant experience may be considered.
- 0–2 years of experience in a regulated industry, preferably medical devices, pharmaceuticals, or biotechnology.
- Familiarity with global medical device regulations, including FDA QSR, ISO 13485, MDR, and/or MDSAP.
- Understanding of CAPA, audits, nonconformance management, Good Documentation Practices, and quality system principles.
- Strong attention to detail, data integrity, organization, communication, and cross-functional collaboration skills.
- Experience with UDI systems, product regulatory compliance processes, or electronic Quality Management Systems is preferred.
Culture & Benefits
- Work focused on improving outcomes for patients with critical cardiopulmonary and respiratory conditions.
- Culture emphasizing innovation, self-motivation, and an entrepreneurial spirit.
- Comprehensive employee benefits are available.
- operates in more than 140 countries.
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