国际人才招聘职位信息

职位编号: C6420

Global Validation Lead

这是一个Regular招聘信息

雇主: Elos Medtech

工作地点: 天津

工作地址: Tianjin, China

工作类型: 全职(办公室)

行业&领域: 制造/生产/组装, 医疗产品与设备

职位数量: 1

薪水: 面谈

联系人: HR

更新日期: 2025/2/21

有效期至: 2025/4/23 Expired

职位描述:

Closing on: May 30, 2025

Job Category: IT

Job Type: Full Time

Job Location: Tianjin

Country: China

We are seeking an experienced Global Validation Lead to join Elos Global IT team to lead and execute validation activities for our digitalization projects and implemented global applications.

Elos Medtech is a company in growth and in a transition phase. We are on the path of becoming a data-driven and digitalized Medtech company, focusing on building an eco-system of best of breed applications to support our business needs.

As we evolve, it becomes increasingly crucial to maintain our digital ecosystem in a validated state. This is why we are seeking a Validation Lead who can ensure that our systems and processes adhere to stringent regulatory standards and software validation requirements according to ISO13485. By joining our team, you will play a pivotal role in safeguarding the integrity of our operations. We prioritize digitalization and here you will have a say in our direction and methods. Engage in interesting IT transformation projects, with a focus on Cloud and Integration Platform as a Service (iPAAS). Join us for a fulfilling role where you can contribute to our digitalization journey and be part of a dynamic team!

Responsibilities

Lead and execute validation activities in global projects

Define validation strategy

Impact assessments

Risk assessments (regulatory and functional)

Define test strategy

Documentation

Evaluating if new releases require re-validation

If you have a passion for validation and find yourself in the above criterias, we want to hear from you! This is an exciting opportunity to lead the validation of critical global systems that will help us to drive our business forward and achieve our digitalization strategy.

资历和要求:

Requirements

Bachelor’s degree in engineering, computer science or a related field

5+ years of experience of Computer Software Validation (in a medical industry)

Knowledge about MES, ERP, iPAAS.

Experience from working in Life Science industry.

Detailed knowledge of FDA Standard for electronic signatures and electronic records (21 CFR Part 11) as well as the GAMP 5 approach for Software validations.

Fluent in English, both verbal and written

Excellent communication, problem-solving, and decision-making skills

Bonus

Experience with Cloud System Validation

In this role, occasional travel is required to support various projects and initiatives

薪水和福利:

That is why you must apply

You will get an attractive job in an international company that has a strong focus on digitization and where quality and high precision is in our DNA.

Become part of a flat organization with an informal tone, humor, and positive attitude as an important part of everyday life.

Focus on employee well-being with flexibility, joy, and development in the job.

Elos Medtech provide a market-competitive salary based on qualifications and experiences.

Submit your application now!

雇主介绍:

Overview
Elos Medtech employs 1,500 people across five business units – Orthopaedics, Dental, Spine and Procedure Kits, Precision, and Life Science. We are a powerhouse in medical devices and one of the top 10 CDMO companies in the world.

We provide local service with a global reach. Since our acquisition of the Klingel Group in 2023, we now operate from 13 sites in six countries; China, Denmark, Germany, Sweden, Switzerland and the US.

Elos Medtech’s specialized Business Units offer expertise while our collective knowledge ensures access to the latest innovations. Our extensive portfolio includes implants and instruments for dental and spine surgery; advanced precision molding tools; high-precision components and instruments for robot-assisted and augmented reality; and full-service provider for validation, sterile packaging and logistics of medical implants, instruments and consumables.

At the core of our operations lies an unwavering commitment to putting the customer at the heart of what we do. This is exemplified by our holistic approach from design to delivery, ensuring quality remains uncompromised. With a profound awareness of the millions of patients worldwide who rely on our products, we go the extra mile by fostering enduring partnerships rather than settling for transactional arrangements.

Website
https://elosmedtech.com/

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