Quality Engineer

正在寻找WHAT WE'RE LOOKING FOR:

• 本科及以上学历,化工、材料、药学类及相关专业;Bachelor's degree or above, majoring in Chemical Engineering, Materials Science, Pharmacy or related fields;
• 熟悉ISO9001质量管理体系要求;Familiar with ISO9001 quality management system requirements;
• 熟悉GMP 要求或ISO13485质量管理体系; Familiar with GMP requirement or ISO13485 system

经验EXPERIENCE:

• 具备2年及以上质量保证或新项目管理的工作经验。At least 2 years work experience in quality assurance or new project management.

胜任工作要求THOSE NECESSARY TO PERFORM THE JOB COMPETENTLY:

• 有一次性耗材的质量管理经验优先;Experience in quality management of single-use product is preferred.
• 有医疗器械、药包材、药品相关的新项目管理经验者优先。Experience in new project management related to medical devices, pharmaceutical packaging materials, and drugs is preferred.

必要资质PREFERRED QUALIFICATIONS:

• 精通Office办公套件(Excel、PPT、Word);Proficient in Office suite (Excel, PPT, Word).
• 扎实的书面和口头沟通技巧;Solid written and verbal communication skills.
• 具备一定的分析数据的能力;Have a certain ability to analyze data.
• 优秀的英语读写能力;Excellent English reading and writing skills.
• 有良好的沟通能力和团队协作能力,有较强的责任心;Has good communication and teamwork skills, and a strong sense of responsibility.
• 具有质量控制计划制定的能力/经验。Ability/experience in developing quality control plans.

工作描述HOW YOU WILL THRIVE AND CREATE AN IMPACT:

• 新产品导入,制定质量控制计划Involve in NPI projects and responsible for new project quality control plan development.
• 新产品的质量控制First article and proto type product quality management.
• 协助工艺验证,制定验证质量标准Assist in process validation, develop validation quality standard.
• 新产品灭菌验证管理New product sterilization validation management.
• 新产品/物料保质期研究管理New product/raw material shelf life study.
• 编制产品验证指南Develop product validation guide.
• 新薄膜、管子、接头等物料国产化项目的工厂内部质量支持Quality support inside factory on new sourced localization film, tubing, connectors etc.
• 常规和新物料的资料检查/核查Data/certificate inspection/verification of regular and new components.
• 协助新工厂、新实验室的验证Assist in the validation of new facility and lab.

Disclaimer:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

Why Avantor?

Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science.
 
The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor.
 
We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today

EEO Statement:

We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law.

If you need a reasonable accommodation for any part of the employment process, please contact us by email at  and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address.

3rd party non-solicitation policy:

By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation