職位描述
Responsibilities:
1. Validation uation for new or modified process/equipment system/facility.
a) Process characterization study.
b) Identify key process variables that would affect product quality.
c) Identify equipment critical part/feature that would affect process parameter and product quality.
d) Hazard Analysis/risk assessment and other process study.
e) Develop VMP for whole processes of production by product with necessary justifications based on above assessment/study.
2. Design and develop validation protocol.
a) Design validation study features, such as sampling, testing, or analytical methodologies.
b) Direct validation activities, such as protocol creation or testing.
c) Prepare validation protocols for new or modified manufacturing processes, systems, or equipment for medical, electronics, or other types of production.
d) Study product characteristics or customer requirements to determine validation ives and standards.
3. Conduct validation or qualification tests based on internal protocols and/or external standards.
a) Assist in training operators or other staff on validation protocols.
b) Analyze validation test data to determine whether systems or processes have met validation criteria or to identify root causes of production problems.
c) Coordinate the implementation or scheduling of validation testing with affected departments and personnel.
d) Identify deviations from established product or process standards and provide recommendations for resolving deviations.
e) Manage deviations and changes in order to guarantee that these are well documented and corrective s are taken and followed-up upon.
f) Draw samples of raw materials, or intermediate and finished products for validation testing.
g) Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements.
h) Procure or devise automated validation test stations or other test fixtures and equipment.
i) Align facility validation strategies and policies with actual outcomes
4. Continuous competence development in Validation and maintenance of validation documentation and database.
a) Communicate with regulatory agencies regarding compliance documentation or validation results.
b) Participate in internal or external training programs to maintain knowledge of validation principles, industry trends, or technologies.
c) Prepare, maintain, or review validation and compliance documentation.
d) Create, populate, or maintain databases for tracking validation activities, test results, or validated systems.
5. Deal with other assignments assigned by superior.
Qualification:
1. College degree or above, major in electronics, electromechanical or equivalent.
2. Above 5 years relative work experience, QA experience is a plus.
3. Good command of written English.
4. proactive, responsible, independent.
企業(yè)介紹
公司簡介
秋時電子(深圳)有限公司成立于1996年12月20日,擁有過硬的工程技術(shù)和生產(chǎn)管理經(jīng)驗,專門為客戶提供復雜工藝產(chǎn)品和精密度高的產(chǎn)品。公司在香港和美國分別設(shè)有辦事處。
公司的主要產(chǎn)品有光學儀器、全自動電子美容器、電子/醫(yī)用傳感器、瞄準器、透鏡、工業(yè)控制器、信號計數(shù)器以及PCBA等。產(chǎn)品100%外銷歐洲以及北美,公司以高效的服務(wù)、卓越的品質(zhì)深得客戶信賴,已經(jīng)取得BSI ISO9001:2008及 BSI ISO13485:2003的認證。
發(fā)展目標
1. 成為歐洲以及北美客戶在中國地區(qū)首選制造商。
2. 成為低成本、高品質(zhì)的一流制造商。
3. 成為使員工最有成就感和歸屬感的優(yōu)秀企業(yè)。
薪資與福利
1. 公司提供富有競爭力的薪酬。
2. 公司實行5天8小時工作制度。
3. 按國家規(guī)定提供社會保險及住房公積金。
4. 每年7天有薪年假,且享受年終雙薪。
5. 公司為每位員工提供餐補及安全舒適的住宿(或房補)。
6. 公司設(shè)有種類眾多的獎項:優(yōu)秀員工、終身榮譽獎、杰出貢獻獎等。
7. 其他福利:部門娛樂活動經(jīng)費、生日禮金、結(jié)婚禮金、生育禮金、節(jié)日禮品或禮金、喪葬慰問金、出差補貼、年終聚餐及抽獎、員工專業(yè)技能培訓、學歷教育、戶口招調(diào)等。
聯(lián)系我們
公司地址:深圳市南山區(qū)西麗白芒南崗第一工業(yè)區(qū)8棟
乘車路線:市內(nèi)方向乘392、332、316、326、325于“白芒關(guān)”站臺下車,往出關(guān)方向前行100米;石巖乘392、332、316、326、325于“南崗工業(yè)區(qū)”站臺下車。
熱誠歡迎您加盟秋時電子,成為秋時精英的一員。
Quasar electronics (SZ)co., Ltd was established in Shenzhen, China in 1996, giving us time to build a strong Management System. Engineering Support and Project Management functions are geared towards meeting international customer requirements, giving customers serious communication & clear cooperation. We has offices in Hong Kong and the United States.
Quasar excels in manufacturing complex and/or precision products, which require consistent quality & yields; High Precision Assembly, such as optics, sensors (medical/industrial), and products assembled under a microscope. Complex products may involve many different types of parts/components assemblies: SMT, Thru-hole & COB, metal, plastic, and silicone-rubber, among others. Alternatively, different types of assembly methods: swaging, ultrasonic welding, calibration, testing, clean room, & consumer packing
Quasar is ISO9001 and ISO 13485 Certified, by BSI, since 1998, initially ISO9002 and in 2002 updated to the present ISO certification.
Quasar manufactures products for the Medical (about 30-40%), Consumer, Telecommunication and Agricultural Markets, among others.