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1 день назад

Site Quality Assurance Engineer (Medical Devices)

75 000 - 95 000$

Формат работы

onsite

Тип работы

fulltime

Грейд

middle

Английский

Страна

Вакансия из Hirify Global, списка международных tech-компаний
Для мэтча и отклика нужен Plus

Мэтч & Сопровод

Для мэтча с этой вакансией нужен Plus

Описание вакансии

Текст:

TL;DR

Site Quality Assurance Engineer (Medical Devices): Supporting manufacturing quality, product complaint investigations, process validations, CAPA, and new product introductions with an accent on regulated medical-device quality systems, statistical analysis, and risk management. Focus on solving product and process issues, analyzing production quality data, leading corrective actions, and ensuring compliance with ISO 13485, ISO 14971, GMP, and FDA requirements.

Location: On-site in Pawtucket, Rhode Island; applicants must reside within a reasonable commuting distance. No relocation is offered.

Annual salary: $75,000–$95,000, plus eligibility for an annual bonus.

Company

ZOLL develops medical devices, software, and related services for diagnosing and treating serious cardiopulmonary and respiratory conditions.

What you will do

Lead product complaint investigations from receipt through resolution and complete related health risk assessments.
Develop and implement quality improvement programs and monitor production quality performance.
Support manufacturing process validations, change control, new product development, and regulatory activities.
Analyze and disseminate quality data, participate in Material Review Board activities, and resolve product nonconformities.
Act as a quality liaison across manufacturing, QA/QC, R&D, regulatory, and project teams.
Support audits and participate in the CAPA program as a trained CAPA lead.

Requirements

BS degree in a science- or engineering-related discipline.
3+ years of related experience in a regulated environment, preferably medical devices.
Experience with ISO 13485, ISO 14971, and FDA Quality System Regulation for medical devices.
Knowledge of statistical analysis, process capability, process control, and measurement system capability.
Strong problem-solving, communication, organization, prioritization, and deadline-management skills.
ZOLL does not provide immigration-related sponsorship; applicants must not require current or future sponsorship, including H1B, TN, STEM, or OPT.

Nice to have

ASQ Certified Quality Engineer certification.

Culture & Benefits

Work in a medical technology environment focused on improving patient outcomes.
Collaborate with teams supporting EMS, hospitals, public safety, and military customers.
Culture values innovation, self-motivation, and an entrepreneurial spirit.
Comprehensive benefits and annual bonus eligibility are provided.

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