Quality Compliance Specialist
2 months ago
Job Summary
We are seeking a highly skilled Quality Compliance Specialist - Medical Device to join our team at 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. in Suzhou, China. As a key member of our quality team, you will be responsible for ensuring compliance with regulatory requirements and industry standards for medical devices.
Key Responsibilities:
- Assist in the development, implementation, and maintenance of an effective quality management system to ensure compliance with applicable regulations for medical devices, such as Good Manufacturing Practice for Medical Devices, 21 CFR Part 820, and ISO 13485.
- Manage quality management system documents, organize management review meetings, and prepare related data and files.
- Plan and coordinate quality management system internal audits in accordance with available regulations and standards for medical devices.
- Act as a CAPA engineer/coordinator to ensure the effective implementation, evaluation, and monitoring of corrective actions and preventive actions.
- Coordinate with regulatory authorities and third-party audit organizations to ensure compliance with regulatory requirements.
- Perform other tasks assigned by superiors.
Requirements:
- College degree or above.
- At least 3 years of experience in quality engineering or quality management system for medical devices.
- Experience in PCBA and electronics product assembly process.
- Familiarity with medical quality management systems (such as ISO 13485) and relevant regulations on medical devices.
- Knowledge and ability to understand and implement internal audits of QMS.
- Good communication, presentation, interpersonal relationships, and organizational skills.
- Initiative, independent work ability, and good team player spirit.
What We Offer:
- Social Insurance
- Life Insurance
- PTO
Job Category: Quality
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