Specialist I - QA/QE - PHDS

• Performing a wide variety of activities pertaining to compliance with applicable regulatory requirements, quality management system (QMS) maintenance, improvement and harmonization, and quality control and assurance.
• Ensures that appropriate SW Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design
• Provides effective oversight of: the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle
• Can lead quality related problem solving for software like leading root cause analysis and SW Quality problem solving Make a substantial contribution to ways of combining Agile with medical software development
• Support and facilitate the department in enabling and assuring that products are developed and produced in compliance with requirements from applicable standards
• Understanding of global medical device regulations, requirements, and standards, such as 21 CFR Parts 803,806, and 820,ISO13485, ISO 9001
• Responsible for performing timely, detailed SW Quality engineering tasks like: assessing software designs and reviewing test and other performance data, analyses Product Quality,
• You are a part of
• Personal Health Digital Solutions Infrastructure is consumer centric team focused on building innovative digital propositions by using best in class SW Engineering principles with a collaborative and continuous improvement mindset.

To succeed in this role, you should have the following skills and experience

• Background in Quality Software (embedded or Apps
• Bachelor or Master degree in relevant knowledge domain, e.g.: Computer Science, Electronics, Electrical or information technology.
• Knowledge of relevant external standards for Quality Management Systems for medical devices (e.g. ISO13485, ISO 14971, MDR, 21 CFR Part 11 and 820, ISO 9001)
• Knowledge of (software) processes and procedures
• Qualified Auditor of Quality Systems (Preferable)
• Good skills in reporting, both in writing and oral. And an excellent team player with good communication skills.
• Fluent speaker and writer in English
• Project management knowledge and skills
• Knowledge of product creation and (software) development methods & tools
• Experience in using problem solving tools