Product Quality Engineer
A collective energy and ambition. A place where you can make a real difference.
We’re a company that genuinely cares about our people, our products, our consumers and the environment.
Our unique, informal culture champions courage, determination and collaboration. Knowing we have an open and supportive team means each of us has the freedom to take responsibility and ownership. We have a shared passion to work hard, innovate and push boundaries.
United by the belief that when we strive for growth, anything is possible. While we might not be the largest company in our industry, we believe we can have the biggest impact because: Together We Have the Power to Win.
职位Job Title:产品质量工程师Product Quality Engineer
级别Job Grade: CHN Grade-1
部门Department:质量部Quality Department, APAC
上级经理Reports To: Sr. Product Quality Engineer
负责执行全球质量管理流程，管理在中国以及亚太区生产的新产品和上市产品的质量，如：医疗器械、处方药、药品、化妆品、膳食补充剂、食品、动物营养品和其他消费品，以确保产品符合适用的C&D的质量政策、FDA法规、ISO13485标准、MDSAP、MDR以及其他适用的标准和法规。This position is responsible for supporting the implementation of and executing under the Global Quality processes for maintenance and issue management of new and marketed products ensuring compliance with C&D policy, FDA regulations, ISO 13485, MDSAP, MDR and other applicable standards/regulations for diverse product range of Medical Devices, OTC, Drugs, Cosmetic, Dietary supplements, Food, Animal nutrition and consumer products in China and APAC.
Role Accountabilities and Responsibilities (Describe the 5-7 major accountabilities)
• 负责产品的设计评审、项目设计计划、设计变更和风险管理活动的质量评审。Lead quality reviews at defined design reviews, project design plans, design change, and risk management activities.
• 负责创建和评审过程验证方案和报告并协助技术转移。Lead creation and review of process validation and qualification protocols and reports to support successful technology transfer.
• 技术转移和产品放行活动（生产放行和发货放行）的质量负责人。Quality lead for, Tech Transfer, and Product Release activities (RTM and RTS).
• 产品品牌维护和产品拓展升级项目从概念到投放市场过程的质量监督。Quality oversight of brand maintenance and product upgrade/line extension projects from conception to commercialization (both internal and external manufacturing) across the portfolio, including medical devices, OTC drugs, cosmetics, nutritional supplements, animal nutrition and consumer products.
• 协助执行质量问题管理（PQM）系统流程。Support the risk-based Quality Issue Management (PQM) process that is compliant to all applicable Health Authority regulations, effective, efficient and agile.
• 主导评估“教训总结”，实施改善行动并识别潜在趋势以指定改善行动。Champion “lessons learned” reviews, implement key outputs and identify potential trends for improvement initiatives.
• 将不合规事项报告给管理层并按按要求协助采取现场行动。Escalate areas of non-compliance to the Management and support field action activities as directed.
• 协助产品的风险管理并将潜在风险汇报给管理层Support risk management activities across all product categories and escalate areas of the potential risk to Management
• 了解技术和合规问题，跟相关专家沟通并确定风险因素并将其汇报给上级经理。Develop an understanding of technical & compliance issues, interface with subject matter experts, identify risk elements & communicate them to leadership.
• 协助供应商质量管理团队关于质量问题管理、根本原因分析和纠正预防措施计划等的制定和实施。Support supplier quality teams in issue management, root cause analysis, and CAPA plan development.
• 负责跟生产工厂和R&D联系关于质量问题的管理、改善行动和偏差评估。Act as liaison between manufacturing sites and R&D in issue management, improvement initiatives, and deviation evaluations.
Education and Experience
• 药学、化工、科技、工程、食品专业本科学历BS in an appropriate discipline (Pharmacy, Chemistry, Science; Engineering; Food).
• 5年以上化妆品、食品或医疗器械质量管理体系经验Minimum of 5 years’ experience in Quality Management System in cosmetics, foods or medical device.
• 具备支持多项目能力，并作出合理判断以达到项目目标Ability to work on multiple projects, exercise sound judgment, and meet project objectives.
• 熟悉ISO 9001, ISO22716, ISO13485 和 HACCP质量体系 Familiar with ISO 9001, ISO22716, ISO13485 and HACCP
• 熟悉化妆品、医疗器械和食品的法规要求Good knowledge of local regulations on cosmetics, medical device and foods.
• 具备六西格玛工具的使用技能和经验Skills and experience in six Sigma tools.
• 具备供应商审核的技能和经验Skills and experience in supplier audits.
• 英语书写口语流利Fluent in written and oral English.
• 良好的沟通技能Good communication skills.
COVID VACCINE REQUIREMENT*: To support the health and safety of our team members, successful candidates for employment in this role must (1) be fully vaccinated against COVID-19 as defined by the Centers for Disease Control and Prevention (CDC) and to have submitted proof of vaccination status, or (2) request and receive an approved accommodation based on medical circumstances or sincerely held religious beliefs, practices or observances.
*Only applicable for Corporate positions based in Princeton, NJ and Ewing, NJ
Church & Dwight is proud to be an Equal Opportunity Employer/Veterans/Individuals with Disabilities.
For more information on our company, our brands and our culture visit us at http://www.churchdwight.com/
DIVERSITY At Church & Dwight
Church & Dwight strives to create an environment where everyone feels free to bring their authentic self to work every day.
We win when we respect every employee for who they are – regardless of gender, age, race, ethnicity, religion, disability, veteran status, sexual orientation or any other differences. We believe that our employees’ contributions are richer because of their diversity. We aim to be a diverse, inclusive and equitable company and are determined to build a culture where people have the power to win together.
CULTURE At Church & Dwight
We care - about our people, our products, our consumers and our environment. To honor these priorities, we’ve built our culture around the tenants of courage, determination and team spirit. We’re united by our small company feel and inspired by opportunities to make our mark.Learn More
Equal Employment Opportunity for the Disabled At Church & Dwight
As an equal opportunity employer, Church & Dwight is committed to providing access and opportunities to individuals with disabilities. Applicants who require accommodation in the job application process may contact 877-809-8449 or email their resume and cover letter to email@example.com. Please note that these options are available only to those needing an accommodation because of a medical condition or disability. All email submissions should include “Accommodation needed” in the subject line as well as information related to the specific position you are interested in (requisition number, job title, location, etc.). Church & Dwight will not respond to inquiries made to firstname.lastname@example.org or 877-809-8449 that are not related to accessibility of the online application system by persons with medical conditions or disabilities. To review Church & Dwight’s Equal Opportunities Employer Policy, click link below.Learn More