Senior Quality Assurance Specialist

18 hours 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.

  • Senior Quality Assurance Specialist

    18 hours ago

    Suzhou, Jiangsu, China Danaher Full time

    Job SummaryWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Danaher. This is an exciting opportunity for a quality assurance professional to contribute to the success of our organization.About UsDanaher brings together science, technology, and operational capabilities to accelerate real-life impact. We partner with...

  • Senior Quality Assurance Specialist

    18 hours ago

    Suzhou, Jiangsu, China 898 FLEXTRONICS COMPUTING (SUZHOU) CO., LTD Full time

    Join 898 FLEXTRONICS COMPUTING (SUZHOU) CO., LTD. as a Senior Quality Assurance Specialist and drive quality excellence in our exceptional teams who develop innovative products contributing to our growth.We are seeking an accomplished Quality Assurance Engineer located in Suzhou Wuzhong, reporting directly to the Quality Manager. This critical role will lead...

  • Senior Design Quality Assurance Specialist

    3 weeks ago

    Suzhou, Jiangsu, China Philips Full time

    Job Title: Senior Design Quality Assurance SpecialistAbout the Role:We are seeking a highly skilled Senior Design Quality Assurance Specialist to join our team at Philips. As a key member of our Quality and Regulatory organization, you will be responsible for ensuring the quality and regulatory compliance of our medical devices.Key Responsibilities:*...

  • Senior Quality Assurance Specialist

    18 hours ago

    Suzhou, Jiangsu, China Freudenberg Full time

    Job DescriptionWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Freudenberg.About the RoleThis is an exciting opportunity for a quality professional to work on new product development and ensure the highest level of quality standards are met. The successful candidate will be responsible for implementing and maintaining...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Suzhou, Jiangsu, China Suzhou Littelfuse OVS Co., Ltd. (China) Full time

    Littelfuse is a leading global manufacturer of electronic components, serving over 100,000 end customers across various industries. As a company, we strive to empower a sustainable, connected, and safer world.About the JobWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team. In this role, you will be responsible for...

  • Quality Assurance Specialist

    2 weeks ago

    Suzhou, Jiangsu, China SRG Global Full time

    Quality Assurance Specialist Role SummaryAs a Quality Assurance Specialist at SRG Global, you will be responsible for ensuring the highest quality standards in our products and services. This role requires a strong understanding of quality management principles and the ability to apply them in a fast-paced manufacturing environment.Key...

  • Senior Quality Assurance Specialist for SiC Customer Relations in ME

    18 hours ago

    Suzhou, Jiangsu, China Bosch Full time

    Job Title: Senior Quality Assurance Specialist for SiC Customer Relations in MEAt Bosch, we're looking for a highly skilled and experienced professional to join our team as a Senior Quality Assurance Specialist. This role will be responsible for ensuring customer satisfaction by handling quality-related topics, improving communication with customers, and...

  • Quality Assurance Specialist

    2 weeks ago

    Suzhou, Jiangsu, China Barco Full time

    Job Description:The Quality Assurance Specialist will be responsible for the qualitative processing of defect reports towards suppliers within agreed time frames.Key responsibilities include communicating defect reports to suppliers and quality managers, deciding upon feedback formats with suppliers, and ensuring timely defect report processing.Additionally,...

  • Quality Assurance Specialist

    4 weeks ago

    Suzhou, Jiangsu, China Bosch Full time

    Job DescriptionAs a Quality Assurance Specialist at Bosch, you will be responsible for ensuring the quality of our products and processes. Your key responsibilities will include:Key ResponsibilitiesProcess owner for claims processing in the plant: recording, evaluation, and conclusion of all claimsSecure short-term delivery of production in the event of a...

  • Quality Assurance Specialist

    18 hours ago

    Suzhou, Jiangsu, China Gunnebo Entrance Control Full time

    At Gunnebo Entrance Control, we are seeking a highly skilled Quality Assurance Specialist to join our team. The successful candidate will be responsible for ensuring the quality of our products meets global standards.As a key member of our production department, you will work closely with our manufacturing team to achieve high-quality results. Your attention...

  • Senior Quality Assurance Specialist

    2 weeks ago

    Suzhou, Jiangsu, China KCC KONE Elevators Co. Ltd Full time

    Quality Assurance and Quality Control RoleAbout the JobKCC KONE Elevators Co. Ltd is seeking a highly skilled Senior Full-Chain Quality Engineer to join our team. The successful candidate will be responsible for leading quality improvement initiatives and ensuring the highest standards of quality in our products.Key ResponsibilitiesEvaluate and improve our...

  • Quality Assurance Specialist

    3 weeks ago

    Suzhou, Jiangsu, China Phillips-Medisize Full time

    Your RoleAs a Quality Assurance Specialist at Phillips-Medisize, you will be responsible for ensuring the highest standards of quality in our products.Our TeamOur team is a collaborative and dynamic group of professionals who are passionate about delivering exceptional results.Key ResponsibilitiesDevelop and implement quality assurance processes to ensure...

  • Quality Assurance Specialist

    4 weeks ago

    Suzhou, Jiangsu, China Wärtsilä Full time

    Quality Assurance SpecialistAt Wärtsilä, we are committed to delivering high-quality products and services that meet the needs of our customers. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products and processes meet the highest standards of quality.Your Key Responsibilities:Conduct regular audits and inspections...

  • Quality Assurance Specialist

    2 weeks ago

    Suzhou, Jiangsu, China Wärtsilä Full time

    Quality Assurance SpecialistAt Wärtsilä, we are committed to delivering high-quality products and services that meet the needs of our customers. As a Quality Assurance Specialist, you will play a critical role in ensuring that our products and processes meet the highest standards of quality.Your Key ResponsibilitiesConduct regular audits and inspections to...

  • Quality Assurance Specialist

    4 weeks ago

    Suzhou, Jiangsu, China SRG Global Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at SRG Global. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards are met in our manufacturing processes.Key ResponsibilitiesCollaborate with customers and suppliers to resolve quality issues and improve...

  • Quality Assurance Specialist for Instruments

    3 weeks ago

    Suzhou, Jiangsu, China Danaher Full time

    Job Summary:We are seeking a Quality Assurance Specialist for Instruments to join our team at Danaher. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our instruments and equipment.Key Responsibilities:Develop and implement quality assurance procedures for instruments and equipment.Conduct quality audits and inspections...

  • Quality Assurance Specialist

    4 weeks ago

    Suzhou, Jiangsu, China Maquet (Suzhou) Co, Ltd. Full time

    About the RoleWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at Maquet (Suzhou) Co, Ltd. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our medical devices and equipment.Main Responsibilities1. Develop and implement quality control measures to ensure compliance with...

  • Quality Assurance Specialist

    4 weeks ago

    Suzhou, Jiangsu, China Mondelēz International Full time

    Drive Quality and Excellence at Mondelēz InternationalMondelēz International is a leading company in the snacks business, and we're seeking a skilled Quality Assurance Specialist to join our team.About the RoleYou will lead the plan-do-check-act (PDCA) process of our site quality management system and report results to the quality section manager.Your Key...

  • Quality Assurance Specialist

    3 weeks ago

    Suzhou, Jiangsu, China Danaher Full time

    **Quality Assurance Services**We are seeking a skilled Quality Assurance Specialist to provide inspection activity, external/internal audit support and preparation, DMR review/product shipment inspection, NCMR handling, customer feedback/complaint handling, DCP/CO implementation follow, and participate in project transfer and draft/update related...

  • Quality Assurance Specialist

    4 weeks ago

    Suzhou, Jiangsu, China Gunnebo Entrance Control Full time

    Gunnebo Entrance Control is seeking a Quality Assurance Specialist to ensure that our products meet the highest standards of quality and safety. As a key part of our manufacturing process, you will conduct inspections of incoming materials, in-process assemblies, and finished products to ensure compliance with established specifications.Key...