PROJECT QUALITY ENGINEER (INTERIM FULLTIME M/V)
Project Quality Engineer
(INTERIM, Assigment 2 years, fulltime, M/V)
Functie omschrijving Project Quality Engineer (INTERIM fulltime M/V)
The Project Quality Engineer owns validation, maintenance and calibration processes, and supports on the implementation project for MDR. The Project Quality Engineer CDC will be the specialist and offers QMS advice, information and support to management, supervisors and employees in terms of Value Added Services changes or additions, also in such a way that the organization keeps meeting all Legal, Corporate, ISO 13485, FDA RAQA and other requirements. This role ensures a standardized and structured approach to Postponement QMS integration which will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.
Key Activities & Accountabilities
Validation process ownership and site validation compliance according the companies and ISO/QSR standards;
- QMS Process controls out of Risk Assessment;
- NC/CAPA finding ownership and support roles (NC, Root Cause Analyses, CAPA assessor);
- Owning QMS Value Added Services integration including assuring correct and timely closure of projects;
- QMS Projects and status reporting to stakeholders;
- KPI’s, KPI target results and Continuous Improvement for the owned processes;
- Any other RAQA activities as defined by the RAQA Manager
Functie eisen Project Quality Engineer (INTERIM fulltime M/V)
- Bachelor degree required, preferable in Industrial Engineering or equivalent study;
- Knowledge of logistics processes, RAQA and preferably Kitting, Labeling or other MD manufacturing activities;
- Ability to prepare plans, monitor, report status, drive team performance regarding delivery and budgets;
- Knowledge of ISO 13485 and FDA Medical regulations;
- Knowledge of Risk assessments, Root Cause Analyses, complaints handling;
- MS Office advanced experience;
- Excellent communication and interpersonal skills.
- Experience with International Standards (e.g. MDD/MDR/FDA etc.) Solid understanding of and experience in logistics and project planning;
- Solid understanding and 2-3 years working experience with SAP ERP;
- Solid understanding of European Medical Device Regulation; Specifically on Economic Operators.
- A minimum of 7 - 10 years’ experience in similar Quality role;
- Experience of working in the Medical Devices or other regulated Industry.
- Experience of working in an ISO13485 and/or FDA medical devices related compliant environment and on MD Risk assessment (preferably FMEA) and QMS integration;
- Customer and Service minded, Hands-on, Proactive; Structured, tidy and precise; team player.