Company

The Quality Engineer will be based at a division of an international organization, one of the Global Leaders in Medical Devices Industry. The division is a young and ambitious team of 13 fte, they are located in the Yes!Delft incubator, an initiative of TU Delft with a modern atmosphere and an informal culture. They have a passion for software they create and the services they deliver to their customers. They value a freedom and responsibility-based work culture.

Purpose of the job

As a Quality Engineer, you drive the execution and improvement of key quality system processes of the company, to assure that they are in compliance with current and emerging international medical device regulations, and are harmonized with the companies corporate procedures.

You work in a motivated team that meets ambitious deadlines.

Main tasks

• As part of the ongoing harmonization and alignment of the division’s quality management system with that of the corporate organization, you perform procedure change assessments, and create and update procedures, and perform document control activities;
• You coordinate training for the division; this includes tool administration, and assigning training and training evaluation;
• You are the coordinator of CAPA’s; this comprises both progressing the phases as well as performing analysis and implementation tasks in close cooperation with your colleagues;
• You are leading the supplier assessments, approvals and monitoring processes;
• You participate in the division’s internal audit program;
• You will be part of the QA team and will be reporting to the Quality and Regulatory Manager of the division.

Interested?

Please send your resume via this website or call for further inquires to Noblesse Recruitment, Monique Nobel tel. +31 6 41 576 904.

Requirements

• This job requires a bachelor’s degree, and work experience of at least 3 years in a quality position;
• You are experienced with CAPA processing and Complaint Handling;
• You have knowledge of the ISO 13485 standard;
• Preferably you have an internal auditor certificate;
• You are fluent in English, both written and spoken, Dutch is preferable;
• You understand the concepts of software development processes;
• You have eye for detail, and you are pragmatic and result-oriented;
• You are a team player and an effective communicator;
• You take an active stance and don’t wait for things to come your way;
• You are flexible and you are comfortable being part of a young and ambitious team.