4 часа назад
Advanced Engineer DQA (Medtech)
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
Advanced Engineer DQA (Medtech): Leading quality-focused product development and project management for new product introduction, with an accent on process validation, supplier quality, regulatory documentation, and experimental testing. Focus on resolving product and supplier issues, managing CAPA/SCAR and change requests, conducting design and risk reviews, and coordinating qualification and validation testing.
Location: Shanghai, China; frequent travel of at least 30% is required.
Company
operates in the medical device and healthcare products domain, with work involving product quality, supplier management, and regulatory compliance.
What you will do
- Lead project management and product development activities during new product introduction, working with R&D, product management, and other cross-functional teams.
- Define and implement testing strategies, process controls, validation methods, inspection procedures, and product improvement initiatives.
- Design experimental testing and analyze data with statistical quality tools to reduce defects and failure rates.
- Collaborate with suppliers and stakeholders across R&D, product management, regulatory affairs, sourcing, and quality functions to resolve complaints and improve supplier quality.
- Manage NCMR and Deviation quality decisions, CAPA/SCAR implementation, supplier change requests, and final release risk acceptance.
- Maintain product documentation and coordinate qualification and validation testing with internal and external laboratories.
Requirements
- Understanding of ISO 13485 or ISO 9001 quality system requirements.
- Ability to interpret product specifications, drawings, and technical documentation.
- Experience with FMEA, control plans, MSA, PPAP, and other quality methodologies.
- Experience with product development, Design Control, Risk Management, technical files, Device Master Records, and regulatory documentation such as 510(k) submissions and Letters to File.
- Strong leadership, collaboration, influencing, and cross-regional communication skills.
- Fluent English is required; proficiency with MS Office and Adobe tools is also required.
Culture & Benefits
- Health insurance, life and disability coverage, 401(k) contributions, and paid time off are available to employees working at least 30 hours per week on average.
- Employees working fewer than 30 hours per week receive 401(k) access, Employee Assistance Program access, Employee Resource Group access, and Employee Service Corp access.
- Inclusive workplace focused on belonging, diversity, professional growth, and providing resources for effective work.
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