Senior Quality Assurance Specialist

1 month ago

Suzhou, Jiangsu, China 2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. Full time

Company Overview

2011 Flextronics Electronics Technology (Suzhou) Co., Ltd. is a leading provider of electronic manufacturing services, and we're committed to delivering high-quality products that meet our customers' needs.

Job Summary

We're seeking a highly motivated Senior Quality Assurance Specialist - Medical Devices to join our team in Suzhou, China. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality in our medical devices production process.

Job Description

As a Senior Quality Assurance Specialist - Medical Devices, you will have the opportunity to work on a wide range of projects, from developing and implementing quality management systems to conducting internal audits and implementing corrective actions. Your primary responsibilities will include:

  • Quality Management System Development

You will assist the MRA Manager in developing, implementing, and maintaining an effective quality management system to comply with applicable regulations for medical devices, including Good Manufacturing Practice for Medical Devices and 21 CFR Part 820.

Internal Audits and Corrective Actions

You will act as an internal audit coordinator, planning and coordinating quality management system internal audits in accordance with available regulations and standards for medical devices. Additionally, you will ensure that corrective actions are implemented effectively and monitored until closure.

CAPA Implementation

You will assist the MRA Manager in coordinating audit or inspection from third-party notify bodies and regulatory authorities, and participate in customer audit activities.

Quality Document Management

You will assist the MRA Manager in managing quality management system documents, organizing management review meetings, and preparing related data and files.

Other Responsibilities

You will perform other tasks assigned by your supervisor, such as assisting with training and development programs, providing guidance to junior staff members, and contributing to the development of new quality initiatives.

Required Skills and Qualifications

To be successful in this role, you will need to have the following skills and qualifications:

  • Educational Background

You should have a college degree or above in a relevant field, such as engineering, life sciences, or business administration.

Work Experience

You should have at least 3 years of working experience in quality engineering or quality management systems for medical devices. Experience in PCBA and electronics product assembly processes is highly desirable.

Knowledge and Skills

You should have knowledge of medical quality management systems (such as YY/T0287/ISO13485) and relevant regulations on medical devices (Regulations on Supervision and Administration of Medical Devices). You should also have good communication, presentation, interpersonal relationships, and organizational skills.

Initiative and Teamwork

You should have initiative, independence, and a strong sense of teamwork, with the ability to work collaboratively with colleagues across different departments and levels.

Benefits

We offer a competitive salary package, including:

  • Base Salary

$65,000 per annum

Social Insurance

We provide comprehensive social insurance coverage, including health insurance, pension plan, and unemployment insurance.

Life Insurance

We offer group life insurance coverage to all employees.

PTO

You will be entitled to paid time off, including annual leave, sick leave, and public holidays.

Others

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We celebrate diversity and do not discriminate based on age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process.

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