[徵人] Quality Assurance Manager For Medical Device Company
城市/區域: Vista/Fullerton, CA
時間:Immediately
因為找到離家比較近的公司 所以即將離開這家公司
幫忙公司尋求有Quality System and FDA Audit 經驗的人才
這是一個全職的職位 目前公司位於Vista, CA 但八月初會搬到Fullerton, CA
這職位每年都需要跟中國的供應商見面 所以每年必須要能Travel一到兩次
PRIMARY RESPONSIBILITIES
‧ Direct the quality related activities required for medical device
manufacturing.
‧ Develop, establish and implement quality policies and procedures,
inspection plans, quality performance trends and continuous improvement
initiatives and assure that specifications and tolerances are met.
‧ Direct completion of inspection activities based on inventory, equipment
and personnel requirements.
‧ Review inspection data, address non-conforming materials issues and
consistent follow up with vendors and to evaluate root cause of non
conformity.
‧ Follow up with suppliers for non-conforming materials and completion of
corrective action plans.
‧ Maintain approved supplier list and quality test results in conjunction
with supply chain.
‧ Manage corrective/preventive action system. Follow up responses from all
sources and track corrective action activities from all sources.
‧ Direct internal audit activities and scheduled completion.
‧ Participate in third party audits/assessments, recommend and manage
external audits.
‧ Interface/coordinate with customer to address/resolve quality issues and
concerns relative to quality performance, investigation, system audits and
corrective actions.
‧ Manage and maintain calibration program for all inspection and testing
instruments and equipments, as well as all tools and equipment used to
manufacture products.
‧ Monitor the Document Control and Label Control systems.
‧ Act as the Management Representative and oversee the Management Review
Process.
‧ Evaluate supplier’s quality systems overseeing site audits and
manufacturing process capabilities.
‧ Follow up with implemented programs to ensure compliance with GMP’s by
all employees and other personnel in the production facility.
‧ Work closely with suppliers, customers and other departments to meet
quality needs.
ADDITIONAL RESPONSIBILITIES
‧ Excellent problem solving, interpersonal communication and project
management skills a must.
‧ Strong leadership skills that inspire team confidence and respect while
motivating team members in a creative and effective manner.
‧ Must have a desire for achieving excellence in customer satisfaction,
process and product quality and reliability.
KNOWLEDGE AND SKILL REQUIREMENTS
‧ Experience with Change Order Process (CO, ECO, DCN)
‧ Proficient with Microsoft Office
‧ Experience in FDA Quality Systems, ISO 9000, EN 46001, and ISO 13485
requirements is a plus
‧ BS/BA degree in science, engineering or related discipline.
‧ Minimum of 3 years of quality assurance experience, and 3 years at
management position.
‧ Able to travel internationally.
‧ Bilingual (Cantonese/Mandarin) is a plus.
WORKING CONDITIONS
Regular office environment and some visits to warehouse and production.
如果職位適合公司願意幫忙辦身分
由於需要找的是 Manager的職位 又需要跟FDA做交涉 並不是IT或電子產業的
所以沒有以上相關經驗的只好說聲抱歉摟
如有興趣 請用英文寄信到Brian.liang@hygeiababy.com
感謝
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◆ From: 99.107.230.169
※ 編輯: brainliang 來自: 99.107.230.169 (07/08 07:13)
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