苏州招聘

职位描述：




JOB TITLE:

Medical Regulatory Affairs Manager (Quality compliance)



COMPANY DESCRIPTION:

Flex is a leading sketch-to-scale solutions company that designs and
builds intelligent products for a connected world. With more than
200,000 professionals across 30 countries and a promise to help make
the world Live Smarter, 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. For more information please visit our careers page at
www.flextronics.com.



* Industry:
Electrical/Electronic Manufacturing

* Type: Public Company

* NASDAQ: FLEX

* Headquarters: 2 Changi South
Lane, Singapore, 486123

* Company Size: 10,001+
employees

* Website: www.flextronics.com



Job
Description

Medical Regulatory Affairs Manager



Requirements

* Bachelor’s degree in engineering or equivalent specialized experience

* 8+ years experience with Quality Assurance programs in a PCBA
manufacturing environment preferred, especially in QMS area

* High Mix - Low volume manufacturing environment experience
advantageous

* PCBA and Mechanical Box Build manufacturing environment experience
advantageous

* Quality related certifications advantageous (ISO Internal auditor
certification)

* FDA 21 CFR part 820 knowledge is preferred

* Professional auditing experience preferable. Quality Audit
certification preferred

* Ability to understand and apply ISO Quality Management System
Standards (ISO 9001, ISO 13485) to improve and sustain results

* Strong organizational, practical mathematical (statistical) skills,
analytical and problem solving skills

* Strong communication, presentation, interpersonal, and organizational
skills

* Ability to conceptualize, analyze, plan and organize projects

* Reasoning skills for problem identification and resolution

* Knowledge and ability to understand and apply process audit
principles (ISO)

* Experience in quality control program operations, to include
standards & measurement techniques

* Ability to apply quality control theories and principles to an
operational environment

* Six Sigma or Lean skills and tools exposure advantageous

* Computer literate; able to utilize MS Office, MS Project



Responsibilities

* Establish and maintain the FDA 21 CFR part 820 QMS in Flextronics
Suzhou;

* Analysis the gap between FDA 21 CFR part 820 requirements and current
procedures, with a general improvement plan to eliminate the gaps;

* Coordinate with all the related productions and support functions to
find the more suitable proposal and implement the plan;

* Actions follow up / audit and corrections made immediately during the
implementation stage;

* Coordinate the 21 CFR part 820 requirement audits by FlexMedical
corporate regulatory team;

* Actions follow up for the corporate audit results;

* Prepare to do the self-registration for Flextronics Suzhou
manufacturer with corporate support;

* Provide quality service to Flextronics’ internal and external
customers in all assigned tasks, while upholding Flextronics Values at
all times;

* Evaluate business goals, identify improvement opportunities and apply
system thinking and problem solving techniques to improve and sustain
product quality and process effectiveness;

* Assist operating units with development and implementation of
corrective and preventive action plans to improve overall ISO
compliance and quality results;

* Plan and execute quality system implementation and team activities to
facilitate changes, especially as it relates to meeting and exceeding
customer expectations;

* Provide quality system expertise in product development projects,
verification, validation and manufacturability involving Operations,
E&TD, PM, Material and other departments;

* Support the maintenance and improvement of the Flextronics Quality
Management System;

* Schedule and perform audit activities, to include pre-audit planning,
audit execution and evaluation and post-audit follow-up and
recommendations;

* Present to managers on improvement projects and activities;

* Compile & write training material and conduct training sessions
on Quality System improvement tools & methodologies;

* Ensure applicability of current quality policies, procedures and
objectives by keeping informed of the latest updates/ modifications
related to ISO quality systems;

* Support the development and administration of the customer corrective
and preventative action, internal non-conformance and Flextronics
Quality Management Systems.



Job Category

Quality



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伟创力简介

伟创力国际有限公司是全球领先的从概念成型到规模量产(sketch- to-scale) 解决方案供应商，为互联世界设计和制造智能产品。公司在 30 多个国家有近 200,000 万专业人士并且助力全世界开创智慧生活 (Live smarter)，并向不同行业和终端市场中各种规模的公司提供创新设计、工程、制造、供应链实时管控和物流服务。

在中国，伟创力占有1250万平方英尺生产面积，其中包括15个生产基地、研发中心、销售办公室以及1个区域支持中心。伟创力的10万员工提供包括但不限于制造设计、核心新品引进、印刷电路板组装、分部装配、总装、测试、外壳及物流的服务。

如欲了解更多伟创力的招聘信息，请访问https://flextronics.wd1.myworkdayjobs.com/en-US/Careers

Flex Overview
Flex is a leading 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 Live smarter, 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.

In China, Flex has amassed 12.5M manufacturing sq.ft. comprising 15 manufacturing sites, R&D & Tech Centres, Sales Office and a Regional Support Centre. Staffed by 100,000 employees, we provide services that include, but are not limited to design, new product introduction (NPI), printed circuit board assembly (PCBA), sub-assembly and full-assembly, test, enclosures, and logistics.

For more information about Flex vacancies, pls access https://flextronics.wd1.myworkdayjobs.com/en-US/Careers