MDR Quality Engineer
We are now looking for a MDR Quality Engineer with experience in the Medical Devices Industry.
The MDR Quality Engineer owns validation, maintenance and calibration processes, supports on the implementation and effectiveness on EU Medical Device Regulation.
The Quality Engineer will be the specialist and offers QMS advice, information and support to management, supervisors and employees in terms of manufacturing related activities 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 efficient Manufacturing activities QMS integration related to Medical device Regulation which will also make sure that all external and internal Stakeholders are aware and acting according to their roles and responsibilities.
- Identifying QMS requirements and working with Manufacturing Engineers to efficiently implement.
- Risk management, Validating and auditing Value Added Services ( VAS ) processes and according QMS.
- Monitoring and controlling all activities regarding communication, data transfers, handling the New Process Development.
- Owning effective and efficient QMS VAS integration for MDR including ensuring correct and timely closure of project.
- QMS Projects and status reporting to stakeholders.
- KPI's and Continuous Improvement for the owned processes.
- Any other RAQA activities as defined by the RAQA Manager.
- Solid understanding of and experience in Medical device Directive, medical device Regulation and project planning.
- Understanding and experience in setting up and maintaining Medical device Manufacturing activities.
- A minimum of 1 - 3 years' experience in similar role.
- Experience of working in the Medical Devices industry.
- Experience of working in an ISO13485 and/or FDA medical devices related compliant environment.
- Experience in performing Root Cause Analyses, Risk assessments and consequent QMS integration.
- Customer and Service minded, Hands-on, Proactive.
- Structured, tidy and precise.
- Team player.
- Higher Vocational Education (HBO).
- Knowledge of Medical Device manufacturing activities, Validation and QMS integration.
- Ability to prepare plans, monitor, report status, drive team performance regarding delivery and budgets.
- Knowledge of MDD, MDR, ISO 13485:2016 and FDA QSR Medical regulations.
- Knowledge of process development, Root Cause Analyses, FMEA, or other Risk assessments.
- Excellent knowledge of the English language.
- MS Office advanced experience.
- ERP software experience; Experience with Oracle/SAP would be a plus.
- Experience with International Standards (e.g. MDD / MDR / ISO / FDA QSR).
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