9 дней назад
Quality Engineer (Medtech)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Quality Engineer (Medtech): Establishing and deploying product quality systems in China with an accent on QMS alignment, regulatory compliance, process transfer, and audit readiness. Focus on analyzing quality data, investigating root causes, managing CAPA/NCMR and complaints, and closing audit findings under ISO9001, ISO13485, and FDA 21 CFR Part 820 requirements.
Location: Beijing, China
Company
partners with customers worldwide to develop science and technology solutions for complex challenges.
What you will do
- Establish and deploy product quality systems in China aligned with global QMS and regulatory requirements.
- Transfer product quality processes, standards, and best practices for consistent and compliant execution.
- Lead product quality management and continuous improvement through data analysis and root cause investigations.
- Manage CAPA, NCMR, complaint handling, engineering change control, and audit support.
- Prepare, lead, and support internal and external audits, including timely closure of findings.
- Travel approximately 5%, including occasional overnight and international travel between China and Singapore.
Requirements
- Bachelor’s degree in Engineering or an equivalent qualification.
- 3–5 years of experience in product or manufacturing quality.
- Experience with process transfer, NPI, or site setup is preferred.
- Strong verbal and written communication skills for collaboration with internal and external customers.
- Organized, detail-oriented, proactive, self-motivated, and energetic approach.
- Ability to travel approximately 5% within the assigned territory, with occasional international travel.
Nice to have
- Knowledge of ISO9001, ISO13485, FDA QSR, and China NMPA requirements.
- Familiarity with FMEA, SPC, DOE, and MSA quality tools.
- Cross-site communication and stakeholder management experience.
- Willingness to travel between Singapore and China.
Culture & Benefits
- Full-time position supporting product quality operations in China.
- Work involves collaboration with global teams and customers across different sites.
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