Quality Engineer - Product Development

As a Quality Engineer, you will be responsible for supporting Design Control activities for new product development and life-cycle management. This includes leading cGMP compliance activities on assigned projects end-to-end.

Main Responsibilities:

• Perform quality engineering and assurance tasks for new product introductions and design change projects to ensure that quality-related aspects are regarded sufficiently and timely
• Provide quality engineering support in the development of site validation strategy and plans as well as support the execution of process development, operational and performance qualifications, and overall process validations in accordance with established regulations and applicable procedures
• Support risk management process throughout the entire product life-cycle
• Support Technology Transfer projects of medical devices and drug-device-combination products

About You:

• Experience: Experience in the medical device and/or pharmaceutical industry; experience in medical devices and/or drug-device combination product development and/or life-cycle management
• Soft and technical skills: Collaborate effectively with peers, stakeholders, and partners across the organization to positively impact business results; knowledge of ISO 13485, ISO 14971, MDR, and 21 CFR 820
• Education: Bachelor\’s/Master\’s degree in Engineering or related science discipline
• Languages: Competency in English language to support role responsibilities

About Us:

We provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity. We promote a culture of diversity, equity, and inclusion.