质量与法规专员
Quality & Regulatory Associate
Willow 是一个帮助改善女性生活和健康的系列产品平台。我们是一支以使命为导向的团队，成员包括经验丰富的发明者、母亲和父亲，致力于为女性的生活带来改变。Willow™ 可穿戴式吸奶器被选为 2017 年和 2018 年《时代》杂志评选的 25 项最佳发明之一，并获得 2018 年 CES 创新奖可穿戴技术类别奖项，是我们的平台上的首个解决方案。
职位概述
我们正在寻找一位注重细节的兼职质量与法规专员加入我们的团队。在这个入门级职位中，你将为质量与法规团队提供核心支持，帮助确保我们的产品保持最高水平的安全性、合规性和可靠性。
你将在质量保证和法规事务方面获得实际操作经验，负责产品投诉调查、物料合规性审查以及国际法规文件。这个职位适合希望在快节奏、以使命为导向的环境中开启质量工程、医疗器械或法规合规职业生涯的有抱负的候选人。
主要职责
投诉调查与上市后质量
- 在电子 CRM 系统（salesforce）中记录、审查和评估收到的产品投诉，并为调查提供输入。
- 对退回的产品进行实际操作或技术审查和测试，以确定故障的根本原因。
- 编写简洁、准确且符合规范的调查报告，根据公司 SOP 和法规标准（如 FDA 21 CFR 820、ISO 13485）关闭投诉文件。
- 支持上市后数据分析和月度趋势分析。
物料合规与数据审查
- 审查供应商和第三方检测实验室提供的物料合规性测试报告（如生物相容性、化学安全、REACH、RoHS、Prop 65）。
- 核实技术文档和分析证书，确保原材料和成品符合内部规格和全球标准。
- 跟踪合规数据，并与工程和供应链团队合作解决缺失或不合规的记录。
国际法规支持
- 起草并维护进入国际市场的符合性声明（DoC）和技术文件及其他所需法规文件。
- 协助整理法规提交包并维护全球产品注册记录。
- 监控法规更新以支持共同工作。
查看英文原文
Willow is a platform for products that help improve the lives and health of women. We are a mission-driven team of experienced inventors, mothers, and fathers dedicated to making a difference in women’s lives. The Willow™ Wearable Breast Pump, selected as one of TIME's 25 Best Inventions in 2017 and 2018 CES Innovation Award for Wearable Technologies, is the first solution in our platform.
Role Overview
We are seeking a detail-oriented Part-TimeQuality & Regulatory Associate to join our team. In this entry-level role, you will provide core support to the Quality and Regulatory team to help ensure our products maintain the highest standards of safety, compliance, and reliability.
You will gain hands-on experience across both Quality Assurance and Regulatory Affairs, taking ownership of product complaint investigations, material compliance reviews, and international regulatory documentation. This position is ideal for an ambitious candidate looking to launch a career in quality engineering, medical devices, or regulatory compliance within a fast-paced, mission-driven environment.
Key Responsibilities
Complaint Investigation & Post-Market Quality
- Log, review, and evaluate incoming product complaints in the electronic CRM systems (salesforce) and provide input into investigations .
- Perform hands-on or technical reviews and testing on returned products to determine root causes of failures.
- Author concise, accurate, and compliant investigation reports to close out complaint files in accordance with company SOPs and regulatory standards (e.g., FDA 21 CFR 820, ISO 13485).
- Support with post market data analysis and monthly trending.
Material Compliance & Data Review
- Review material compliance test reports (e.g., biocompatibility, chemical safety, REACH, RoHS, Prop 65) provided by suppliers and third-party testing laboratories.
- Verify technical documentation and certificates of analysis to ensure raw materials and finished goods meet internal specifications and global standards.
- Track compliance data and collaborate with engineering and supply chain teams to resolve missing or non-compliant records.
International Regulatory Support
- Draft and maintain Declarations of Conformity (DoCs) and technical files required for international market access and other regulatory documentation as required.
- Assist in organizing regulatory submission packages and maintaining global product registration records.
- Monitor regulatory updates to support compliance requirements in target international markets.
Quality System Maintenance
- Maintain clear and audit-ready records within the eQMS.
- Assist with document control, change order reviews, and CAPA (Corrective and Preventive Action) support activities.
- Participate in continuous improvement initiatives across quality and regulatory workflows.
Qualifications
Required
- Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Life Sciences, Quality Management, Regulatory Affairs, or a related technical discipline.
- 0–2 years of experience in quality, regulatory, laboratory testing, or engineering (academic projects and relevant internships count).
- Strong technical writing skills and high attention to detail when creating and reviewing documentation.
- Solid analytical and problem-solving skills; ability to interpret test reports and basic engineering specifications.
- Proficiency with standard office software (Microsoft Word, Excel, Google Workspace) and an aptitude for learning specialized systems (eQMS, PLM).
- Excellent communication and time-management skills, with the ability to work independently in a remote or hybrid environment.
Preferred
- Familiarity with medical device regulations or quality standards (FDA 21 CFR 820, ISO 13485, ISO 14971, EU MDR).
- Basic experience using electronic Quality Management Systems (e.g., Arena, MasterControl, Greenlight Guru).
- Prior hands-on experience in a hardware or medical device testing lab setting.
Work Environment
- Work Location: Flexible — available as fully Remote (US/UK-based) or Hybrid (combining remote work with time at our Mountain View, CA office).
- Hours: This is a part-time position of 15-20 hours/week.
Willow is proud to be an equal opportunity workplace. We are committed to equal employment opportunities regardless of gender, race, religion, sexual orientation, gender identity, age, marital status, disability, or Veteran status.
Originally posted on Himalayas