合规工程师岗位职责

岗位职责：
1.隐私合规体系优化与技术落地：参与GDPR、CCPA/CPRA等全球主流隐私法规的合规落地，结合IOT及智能穿戴 产品业务特点，设计并优化隐私合规管理框架与隐私影响评估(PIA)流程；推动合规要求转化为可执行的技术 方案，并嵌入APP/网站开发、产品运营、市场营销、用户调研等业务环节。
2.IoT及智能穿戴产品全生命周期隐私合规支持：
。需求与设计阶段：参与IoT及智能穿戴软件产品需求评审与技术方案设计，输出隐私设计(Privacy by Design)方案，明确数据*小化、用户同意机制、权限控制等设计要求，形成合规检查清单及设计约束条 件；
。开发与测试阶段：进行隐私风险评估，审核数据清单、审核/绘制数据流图(Data Flow Mapping),识别个 人数据的采集、存储、传输链路及第三方SDK合规性中的隐私风险点，推动研发团队制定整改方案并跟踪验 证闭环。
3.隐私技术方案落地与研发协同：与研发团队协作，将合规要求转化为具体技术实现，包括Cookie管理、用户同 意管理(Consent Management)、隐私政策/用户协议管理、数据主体请求(DSR)以及自动化处理方案、数 据跨境传输方案等，并参与相关技术方案的评审与验证。

任职资格：
1.本科及以上学历，计算机科学、信息安全、管理信息系统等相关专业；
2.3年以上隐私合规、数据安全相关工作经验；及一定的技术开发背景；
3.熟悉全球主流隐私法律法规及行业标准；熟悉数据脱敏、加密等隐私保护技术工具；
4.具备一定的技术方案理解与沟通能力(能读懂技术方案、参与技术评审),并与研发团队进行有效的技术层面沟 通；
5.加分项：英语可作为工作语言； 持有CIPP/E、CIPM、CIPT等相关认证； 具备IOT或智能穿戴行业背景； 具备HIPAA相关合规经验。

1、负责玩具、母婴、骑行、杂货、家居家纺等品类的合规管理，重点解读物理安全（如结构强度、小零件、绳带要求）和电学安全（如耐压、绝缘、电磁兼容）相关强制标准，拆解核心合规指标并输出明确的产品合规要求。
2、对接第三方实验室，沟通确认各品类产品的具体测试项目、样品规格、检测方法，实时跟踪测试进度，及时协调解决测试过程中出现的技术问题、样品补充等事宜，确保测试工作高效推进。
3、接收实验室检测报告，解读测试结果，针对不合格项牵头协调研发、生产等团队制定整改方案，推动整改落地并验证整改效果，形成合规闭环。
4、建立并维护各品类合规档案（含标准文本、测试报告、整改记录等），定期更新合规标准动态，向内部团队同步*新合规要求，规避合规风险。
5、配合研发、采购环节的合规前置审核，提供合规技术支持，从源头把控产品合规性，减少后期整改成本。
任职要求：
①学历与行业经验：本科及以上学历，理工科相关专业（如机械、电子、材料、纺织工程等）；3 年以上玩具、母婴、家居家纺或骑行产品行业合规工作经验，熟悉至少 2 个目标品类的物理 / 电学跨境合规标准与检测流程。
②核心能力：具备极强的标准解读与落地能力，能将复杂标准转化为可执行的产品合规要求；沟通协调能力突出，可高效对接实验室及内部研发、生产团队；具备问题解决能力，能快速响应测试过程中的合规异常并推动整改；工作严谨细致，有良好的进度管控和档案管理意识。
③具有第三方实验室条款解读、实验经验等能力优先。
④吃苦耐劳、细节关注度强，良好的抗压能力与应变能力。

Job Summary:
We are seeking a highly skilled experienced Compliance Engineer to join our team. The successful candidate will be responsible fensuring that computerized systems software applications used in the Quasar comply with regulatory requirements industry’s best practices. This role will play a key role in validating maintaining the integrity of our computerized systems, while ensuring adherence to GxP practices agencies regulations.
Responsibilities:
1. Validation Strategy Development: Develop implement comprehensive validation strategies fcomputerized systems, including software, hardware, associated equipment, in accordance with regulatory guidelines (e.g., FDA, EMA, NMPA etc.).
2. Validation Documentation Management: Generate, review, approve validation documentation, including but not limited to validation plans, protocols, risk assessments, reports, ensuring completeness, accuracy, compliance with regulatory requirements.
3. Execution of Validation Activities: Lead and/participate in validation activities such as installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), requalification, ensuring adherence to established procedures timelines.
4. Change Control Management: Assess manage the impact of changes to computerized systems through change control processes, including evaluating change requests, performing impact assessments, updating validation documentation as necessary.
5. Risk Management: Conduct risk assessments fcomputerized systems to identify mitigate potential risks to data integrity, system functionality, regulatory compliance.
6. Quality Oversight: Collaborate with cross-functional teams, including quality, engineering, manufacturing etc., to ensure alignment of validation activities with quality management systems regulatory requirements.
7. Training Guidance: Provide training guidance to stakeholders on CSV principles, procedures, best practices to enhance overall compliance awareness competency within theganization.
8. Continuous Improvement: Proactively identify opportunities fprocess improvements efficiency enhancements in validation activities, driving continuous improvement initiatives to optimize CSV processes systems.
9. Stay current with industry trends, regulations, advancements in CSV practices.
Requirements:
1. Bachelors degree in a related field (Computer Science, Engineering, equivalent).
2. Minimum of 5 years of professional experience in CSV a related field.
3. Strong understanding of GxP practices regulatory requirements (FDA, EMA, etc.).
4. Proven experience in executing IQ, OQ, PQ activities fcomputerized systems.
5. Solid knowledge of IT infrastructure software development life-cycle.
6. Excellent problem-solving analytical skills.
7. Attention to detail ability to work with meticulous accuracy.
8. Strong communication interpersonal skills.
9. Ability to work effectively in a team-oriented environment.
Preferred Qualifications:
1. Certification in CSV related areas.
2. Experience in the Medical Device Manufacturing Life Science.