7 часов назад
Validation Engineer I (Medical Devices)
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
Validation Engineer I (Medical Devices): Supporting supplier qualification, audits, compliance documentation, and corrective actions for a global medical-device supply base with an accent on ISO standards, FDA regulations, and supplier risk management. Focus on conducting audits, investigating nonconformances, applying root cause analysis, and tracking SCAR effectiveness.
Location: Ho Chi Minh, Vietnam
Company
operates a global supply base and manages supplier quality, regulatory compliance, and medical-device quality requirements.
What you will do
- Conduct supplier audits for compliance with ISO 9001, ISO 13485, FDA regulations, and internal quality-system requirements.
- Support supplier qualification, requalification, disqualification, and documentation review for moderate- to high-risk suppliers.
- Execute Supplier Corrective Action Requests by tracking actions, verifying evidence, and documenting effectiveness under supervision.
- Support containment activities and investigations of supplier nonconformances using root cause analysis and risk-management tools.
- Maintain supplier audit, performance, nonconformance, and corrective-action records.
- Prepare reports, dashboards, and summaries covering supplier quality performance and compliance.
Requirements
- Bachelor’s degree in Engineering, Biology, Quality Management, or a related field.
- 3–5 years of experience in supplier quality, manufacturing quality, or a similar role.
- Knowledge of ISO standards, FDA regulations where applicable, statistical process control, and quality tools including FMEA, PPAP, and APQP.
- Experience with medical devices or pharmaceuticals.
- Strong communication, problem-solving, and negotiation skills.
- Willingness to travel up to 25% domestically and/or internationally.
Nice to have
- ASQ Certified Quality Engineer or Certified Supplier Quality Professional certification.
- Six Sigma Green Belt or higher.
- Supplier quality auditing and audit hosting experience.
Culture & Benefits
- Health insurance, life and disability coverage, 401(k) contributions, and paid time off for eligible employees working at least 30 hours per week on average.
- Employees working fewer than 30 hours per week receive 401(k) contributions and access to the Employee Assistance Program, Employee Resource Groups, and Employee Service Corp.
- Inclusive workplace focused on belonging, diversity, and career growth.
Будьте осторожны: если работодатель просит войти в их систему, используя iCloud/Google, прислать код/пароль, запустить код/ПО, не делайте этого - это мошенники. Обязательно жмите "Пожаловаться" или пишите в поддержку. Подробнее в гайде →