職位描述
GMP認(rèn)證ISO認(rèn)證質(zhì)量體系管理醫(yī)療器械
We are looking for a QA Manager who will be responsible for overseeing the development, implementation, and management of quality management systems and regulatory compliance processes for medical devices manufactured in China.
Responsibilities:
- Establish, maintain and continuously optimize the Quality management system (China GMP system) from 0 to 1 for medical device product manufactured in China;
- Act as Quality representative of management team to establish and maintain working relationships with regulatory authorities;
- Lead the review, management and regular evaluation of materials and suppliers
- Ensure that the entire quality system process complies with GMP regulations and can pass the audits and inspections of regulatory authorities;
- Provide necessary support to the current China GSP system to ensure full compliance;
- Provide necessary support to the regulatory activities from QA perspective;
Requirements:
- Expertise in China GMP/ China GSP/ISO 13485 standards
- Solid experience on quality management for full value chain of the entire product lifecycle;
- Capable and skillful for collaboration with different internal BUs (especially with central R&D and QA team), external partners and regulatory authorities;
- Capable to facilitate and drive problem resolving;
- Excellent communication skills in both written and verbal English;
- Education background: Bachelor or above degree major in pharmaceuticals, medical devices or related;
- Solid knowledge about NMPA and EU MDR regulations
- 5 years or above quality working experience in medical device industry, preferable to have experience with GMP system establishment in Shanghai;
工作地點(diǎn)
上海徐匯區(qū)環(huán)貿(mào)iapm商場(chǎng)-二期
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職位發(fā)布者
宋女士/HR
立即溝通
上海依視路光學(xué)有限公司依視路陸遜梯卡集團(tuán)（ISIN：FR0000121667；路透社: ESLX.PA;彭博社: EL:FP）是鏡片、鏡架和太陽(yáng)鏡設(shè)計(jì)、制造和分銷領(lǐng)域的全球領(lǐng)導(dǎo)者，在全球150個(gè)國(guó)家擁有20多萬名員工、650個(gè)生產(chǎn)基地和18000家門店，2023年?duì)I收達(dá)254億歐元。集團(tuán)旗下?lián)碛腥f里路、星趣控、全視線等高科技鏡片品牌，雷朋、歐克利等經(jīng)典眼鏡品牌，廣受歡迎的奢侈品牌以及全球領(lǐng)先的眼鏡零售門店品牌亮視點(diǎn)（LensCrafters）和Sunglass Hut。集團(tuán)旗下基金會(huì)（OneSight）致力于為欠發(fā)達(dá)地區(qū)人群提供視力保健服務(wù)，累計(jì)受益人次超過7.6億。依視路陸遜梯卡集團(tuán)股票在巴黎泛歐交易所上市交易，被列入Euro Stoxx 50和CAC 40指數(shù)。如欲了解更多信息，請(qǐng)?jiān)L問www.essilorluxottica.com【為何選擇我們】-我們開拓創(chuàng)新，攜傳承創(chuàng)未來-我們團(tuán)結(jié)一心，融匯眾人之力-我們靈活高效，化繁瑣為簡(jiǎn)潔-我們滿懷熱情，化靈感為影響力-我們彼此關(guān)愛，身有遠(yuǎn)近心同頻If you’ve worn a pair of glasses, we’ve already met.We are a global leader in the design, manufacture, and distribution of ophthalmic lenses, frames, and sunglasses. We offer our industry stakeholders in over 150 countries access to a global platform of high-quality vision care products(such as the Essilor brand, with Varilux, Crizal, Eyezen, Stellest and Transitions),iconic brands that consumers love(such as Ray-Ban, Oakley,Persol, Oliver Peoples, Vogue Eyewear and Costa),as well as a network that offers consumers high-quality vision care and best-in-class shopping experiences(such as Sunglass Hut,LensCrafters, Salmoiraghi& Viganò and the GrandVision network), and leading e-commerce platforms.Join our global community of over 190,000 dedicated employees around the world in driving the transformation of the eyewear and eyecare industry.Your#FutureInSight with EssilorLuxotticaAre you willing to pioneer new frontiers, foster inclusivity and collaboration,embrace agility, ignite passion, and make a positive impact on the world??Join us in redefining the boundaries of what’s possible!?Our Diversity, Equity and Inclusion commitment?We are committed to creating an inclusive environment for all employees. We celebrate diversity and provide equal opportunities to all, regardless of race,gender, ethnicity, religion, disability, sexual orientation, or any other characteristic that makes us unique.
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