质量保证专员（1年产假替代）
Quality Assurance Officer (1 year maternity cover)
我们是SGS——全球领先的检测、检验和认证公司。我们被公认为可持续性、质量和诚信的全球标杆。我们的99,600名员工在2,600个办事处和实验室网络中工作，共同推动一个更美好、更安全、更互联的世界。
在SGS，我们拥有开放的公司文化和国际氛围。我们在一家领先的全球公司中提供充满活力的工作环境。我们高标准的专业精神和可持续发展方法确保您在一个面向未来的工作环境中工作。我们长期投资于员工，并致力于支持您在公司内部的发展。我们的业务原则包括：诚信、健康、安全与环境、质量与专业精神、尊重、可持续性和领导力。
职位主要职责：
• 维护NB 1639医疗器械内部质量管理体系。
• 管理日常质量保证任务：
· 在MDD、MDR和IVDR框架下更新和维护文件，
· 管理IF数据库，
· 参与通用方案文件的协作，
· 在SGS网站上发布文件，
· Bizzmine（质量管理系统）；用户沟通和维护。
该职位向业务保障部的质量与法规经理汇报。
该职位为远程办公，我们接受欧洲各地的候选人。但候选人必须持有其居住国的有效工作许可。
关键职责：
• 管理投诉、合规查询和申诉，
• 管理持续改进，
• 管理文件控制和记录，
• 对更新的质量管理体系文件进行质量保证检查，
• 在Bizzmine中发布更新的质量管理体系文件，
• 与全球医疗器械认证/能力/技术及临床经理建立良好的工作关系，以及与其他全球医疗器械团队成员合作，
• 承担个人职业发展并确保适当的培训记录得到更新，
• 为公司各部门提供技术支持，
• 保持对SGS程序、法规、指导文件（例如MDCG）和外部批准标准的全面了解，
• 支持联合方案文件的开发和维护。
技能与知识
必要条件：
• 熟悉质量管理体系，包括纠正和预防措施（CAPA）管理、文件控制和良好文件规范（GDP），
• 注重细节或
查看英文原文
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.
At SGS, we have an open corporate and international culture. We offer a dynamic work environment in a leading global company. Our high professional standards and our sustainability approach guarantee you a future-oriented work environment. We invest in our employees for the long term and are committed to supporting your development within the company. Our business principles include: Integrity, Health, Safety & Environment, Quality & Professionalism, Respect, Sustainability, and Leadership.
Main Purpose of Role:
• Maintenance of the NB 1639 medical device internal quality management system.
• Managing of daily QA tasks:
· Updating and maintenance of documents under the MDD, MDR and IVDR scheme,
· Management the IF database,
· Collaboration on generic scheme documents,
· Publishing of documents on the SGS website,
· Bizzmine (Quality Management System); user communication and maintenance.
This role will report to the Quality & Regulatory Manager, Business Assurance.
It is remote based, and we are open to candidates located everywhere across Europe. But they must hold a valid work permit for their country of residency.
Key Accountabilities:
• Management of complaints, compliance queries and appeals,
• Management of continual improvement,
• Management of document control and records,
• Perform quality assurance check on updated quality management system documents,
• Release of updated quality management system documents in Bizzmine,
• Build a good working relationship with the Global Medical Device Certification / Competency /
Technical and Clinical Manager(s), and other Global Medical Device Team members,
• Undertake personal professional development and ensure appropriate training records are
updated,
• Provide technical support to all parts of the business,
• Maintain a full knowledge and understanding of SGS procedures, regulations, guidance
documents (e.g., MDCG) and external approval criteria,
• Support the development and maintenance of combined scheme documents.
Skills & Knowledge
Essential:
• Good working knowledge of quality management systems including CAPA management,
document control and good documentation practices (GDP),
• Detail oriented,
• Strong organisational skills,
• Ability to organise own workload considering priorities set by the global medical device quality
manager,
• Ability to adapt quickly and demonstrate flexibility,
• Ability to work in a team,
• Ability to write clear procedures,
• Good working knowledge of the main MS office tools (Word, Excel, Outlook),
• Fluent written and spoken English.
A nice to have:
• Detailed understanding of global medical device regulations MDR and IVDR, and medical
device directive MDD,
• Knowledge of accreditation standard ISO 17021-1:2015, ISO 13485, ISO 9001.
Experience
Essential:
• Significant work experience in a position with QA responsibility.
A nice to have:
• Experience working with medical devices,
• Auditing experience against recognised standards.
Qualifications
Essential:
• Bachelor’s degree (or higher) in Biomedical Sciences or similar field (e.g., pharmacy, bioengineering, nurse, or similar)
A nice to have:
• Medical device training on MDD, MDR, IVDR or ISO 13485
• Medical device auditor
Performance Indicators:
• Turnaround time for compliance issues/complaints/ appeals,
• Efficient running of QMS and release of quality management documents.
Please send your CV in English
Why SGS?
· Join a globally recognized and stable company, a leader in the Testing, Inspection, and Certification (TIC) industry.
· Enjoy a flexible schedule and work model.
· Access SGS University and Campus for continuous learning options.
· Thrive in a multinational environment, collaborating with colleagues from multiple continents.
· Benefit from our comprehensive benefits platform.
Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfill your potential.
Please share your CV in English. The role is fully remote. People from other countries can apply as well.