QMS Manager (Medical)
Flex
Shanghai
2天前
  • CURRENT EMPLOYEES : Please click here to be redirected to the internal career site. Job Description Flex is the Sketch-to-Scale™ solutions company that designs and builds intelligent products for a connected world ™.
  • With approximately 200,000 professionals across 30 countries and a promise to help the world, the company provides innovative design, engineering, manufacturing, real-time supply chain insight and logistics services to companies of all sizes in various industries and end-markets.

    Flex Live smarter™. Ignite Your Passion : flex.com / careers The QMS Manager(Medical) will be based in Shanghai. We are looking for someone who demonstrates : Intense collaboration Passionate customer focus Thoughtful, fast, disciplined execution Tenacious commitment to continuous improvement Relentless drive to win Here is a glimpse of what you’ll do : Establish, implement and maintain an effective QMS that is compliance with ISO13485, NMPA GMP 64# and any other applicable regulations.

    Work with Corporate regulatory and compliance representative regularly. Work with Training Department to identify training needs and ensure the effectiveness of training provided.

    Conduct internal training / refresher for quality system / compliance / GMP related requirements. Responsible for coordinate and communicate to audit event accordingly with the 3rd party and work with NMPA local government do regulatory compliance inspection.

    Responsible for collecting and staying abreast with the latest applicable standards and regulations by per-forming periodic review and update company QMS accordingly.

    Responsible for organization management review meeting at regular intervals. Responsible for the establishment and management of an effective internal quality audit system.

    Lead and coordinate to all medical customer audits. Drive to improve and optimize the corrective action and preventive action system for medical projects to en-sure compliance with NMPA GMP 64# requirement and customers’ expectation and requirements.

    Document control management work for all projects. Here is some of what you’ll need (required) : College degree or above.

    Minimum 5 years Quality Management System related experience in a medical device environment, with 3 years’ experience in Quality managerial position.

    Ability to understand and apply ISO9001, ISO13485 requirements to improve the quality management system. Good knowledge and ability to understand and apply audit principles and audit skills know-how.

    Good communication, presentation, interpersonal, organizational, analytical and problem-solving skills. Good English in speaking and writing.

    Here are a few of our preferred experiences : Bachelor’s degree or above. Has knowledge of electrical medical device through education or training.

    Experience in Electrical & Mechanical Box Build & Medical Device manufacturing is preferred. Experience in NMPA inspection with hands-on experience in ISO13485 or NMPA GMP is preferred.

    Quality related certification, ISO9001, ISO13485 internal auditor certification is preferred. Professional NMPA GMP knowledge is preferred.

    Professional auditing experience preferable. Lead auditor certification is preferred. Here are a few examples of what you’ll get for the great work you provide : Life Insurance Social Insurance PTO Flex does not accept unsolicited resumes from headhunters, recruitment agencies or fee based recruitment services.

    Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities.

    Flex does not discriminate in employment opportunities or practices on the basis of : 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.

    Flex provides reasonable accommodation so that qualified applicants with a disability may participate in the selection process.

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