Projects and Processes Engineer

In this role, you will bridge the gap between product developers and technical documentation, ensuring manufacturing software and equipment meet the highest standards. Your main responsibilities will include:
Defining & executing validation strategies and activities to launch and sustain manufacturing software and equipment.Developing detailed validation protocols and test cases.Coordinating the Label and Packaging Change Control Board for medical devices, ensuring compliance with international regulations and customer requirements.
Education and Experience
Education: BS in Mechanical, Mechatronics, Electronics, Computer Science, or a closely related engineering discipline.Experience: 3–5 years in QA or software/equipment validation, preferably within the medical device industry or a similar highly regulated environment.Key Knowledge: Strong understanding of Good Documentation Practices (GDP) and international standards (FDA QSR, ISO 13485, ISO 14971, IEC 6230.Skills: Exceptional English writing and verbal communication skills, sharp attention to detail, and the ability to manage multiple projects simultaneously.