深圳招聘

职位描述：
Job Description:

a) Responsibilities
Assure Quality Systems are compliant to the customer Quality requirements as well as regulatory requirements (including FDA Quality System Regulations, GMPs and ISO guidelines, MDD and 93/42/EEC, etc.) throughout all design and manufacturing activities.
Provide Leadership in Quality Excellence for the global business in Systems, People, Processes and Products.
Maintain, improve and drive the comprehensive quality program.

b) Managerial
Define, direct and follow up with all concerned parties in establishing, executing, and monitoring strategic and tactical aspects of product quality programs.
Jointly develop and drive deliverables to meet the company compliance and quality management system goals.
Identify top priority quality issues and develop action plans that support the company business strategy.

c) Strategic
Identify and resolve compliance and quality related issues at the root cause level to prevent problems from re-occurring. Focus on preventive action to minimize resource and schedule impacts.
Review all projects throughout their life cycle for quality improvement opportunities, risks to quality, and counter measures to quality risks.
Develop and deploy an executive level summary on compliance and quality program progress.

Daily Duties include:

Lead the overall quality functions for all facilities including incoming/in-process and outgoing inspection, issue containment and corrective actions.
Work directly with suppliers to dramatically improve overall product quality. Drive improvements to their overall quality systems.
Drive issue resolution with engineering, manufacturing and suppliers.
Oversee the supplier certification program. Ensure supplier report card process is in place. Generate appropriate performance metrics and drive resolution of issues.
Develop and drive department projects such as reducing the need for incoming inspections, vendor to stock improvement, electronic certificates of compliance and parallel audit expansion.
Travel to all facilities/suppliers to review and enhance their effectiveness and capabilities.
Review Quality Assurance plans for NPD including OEM/ODM projects and ensure appropriate quality control processes are in place.
Participate in the supplier selection and qualification process.
Drive timely resolution of issues impacting product quality.
Review Root Cause and Corrective Action reports to verify effectiveness of solutions.
Work directly with Customers, NPD and Production Team to ensure the highest quality level possible products are built.

Position Requirements:

Four Year Bachelor’s degree in an engineering or quality discipline.
Minimum of 8 years quality assurance experience.
Extensive current experience, and successful track record as Quality Manager in either manufacturing operations or international subcontract manufacturing operations.
Strong knowledge of manufacturing quality management in China is a must.
Solid experience in medical device manufacturing field is highly preferred.
Three years experience in Six Sigma Methodology – Black Belt preferred.
(Statistical Process Control, Failure Modes & Effects Analysis, Measurement System Analysis, Process Capability Studies, Corrective & Preventive Action, Root Cause Analysis and Risk Analysis)
Highly motivated individual who can work independently; detail oriented with excellent follow up skills.
Fluency in Mandarin and English language skills a must (written and verbal).
Interpersonal skills - exceptional listening, understanding, influencing and communication (written and verbal), and presentation skills - politically astute. 举报 分享

关于极赛
深圳市极赛科技有限公司坐落于中国深圳宝安区，成立于2008年，注册资金1000万。是一家集研发、生产、销售、售后于一体的ODM/OEM公司。目前公司员工400人，研发人员超过50人。15条组装生产线，30多套测试设备及100多套测试治具。一站式结构, 电子，软件及APP开发，聚焦医疗，健康，及TENS/EMS技术，ISO13485认证单位，产品经过FDA认证。我司主要生产研发医疗保健产品，专注于TENS和EMS技术产品超过20年。

公司文化
公司致力于成为国内外医疗保健行业***、***的高新技术企业。我们的愿景是引领健康行业发展，树立健康科技标杆，我们的使命是帮助人们回归健康，保持健康，享受健康。公司树立了踏实做事，诚信做人的价值观及创造公平正义之土壤，激发个体之潜能的管理理念。我们建立轻松、自由、极致、和平的品牌个性，我们的企业精神是志存高远，向上不止。

企业实力
我司由4家子公司共同构成，与国内外多家大学、医疗机构及专家紧密合作，使得我司研发出来的产品更加的专业可靠。我们的客户有：beurer、waterpik、BODYFRIEND、MEDISANA、GLOBUS等，专注于TENS和EMS技术产品超过20年。主要有理疗发热腰带、EMS腰带、EMS训练设备、EMS眼部治疗设备、艾灸仪、消毒机等其他生物科技产品。

全球市场
我司有60%业务分布在北美和西欧，40%业务分布在亚洲，国内市场以每年40%的增长率增长。

福利：入职即购买五险（医疗保险为一档）；节假日发放礼品；每周有羽毛球活动；不定期举行其他员工活动。
人事部联系方式：0755-23727372