Quality System Engineer, Medication Management Solutions, International Infusion
Job Description Summary
Quality System Engineer, Medication Management Solutions - International Infusion
Eysins / Switzerland
A superb, wide-ranging Quality System Engineer career development role with BD, a global leader in Medical Technology.
BD is a global medical technology company focused on improving drug therapies, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD provides an environment which enables our highly talented workforce to be the best at their professions. We are always seeking people who have a passion and commitment to join our Company on its journey to ‘advancing the world of health’.
Reporting to the Quality Management Director MMS International Infusion, the Quality System Engineerprovides expertise on managing life cycle for Quality System documents and records as per applicable requirements for the scope “MMS International Infusion”.
The Quality System Engineeralso ensures adequate level of controls / governance on training process related to Quality system elements for MMS International Infusion associates. Through proactive communication across organization, effective problem solving and active vigilance on applicable requirements, the Quality System Engineer drives compliance and effectiveness for assigned QMS processes (doc control & Training).
The Quality System Engineer ensure regular reporting through key performance metrics to the Quality Management Director MMS International Infusion.
For assigned QMS elements, success is measured in terms of capacity to monitor compliance and effectiveness. Associate is also expected to develop and participate in the deployment of approved Quality Plans across the organization to support defined strategies and objectives.
Essential Duties and Responsibilities:
- Document & records control process
- QMS metrics collection process
- Quality training process
- Document change control process
- Requires a minimum of technical degree in science, with a minimum of 3 years of relevant experience in the medical device industry. A strong knowledge of WW applicable regulations for Quality systems (ISO13485, 21CFR820)
- The ability to collect dat, analyze situations and propose optimal process solutions to meet both Compliance and Business requirements.
- An individual in this role must have proven leadership, communication, organization and project management skills with a strong orientation on processes.
- The ability to communicate efficiently in an international environment with internal / external customers and key stakeholders.
- A strong working knowledge on managing life cycle documents and records. Deep understanding of change control and training process requirements
- Capacity to work with Product Lifecycle Management system such as Agile / Documentum or Information system such as TrackWise or Learning Management System such as CSOD
- Technical writing skills
- Fluent in English / French an asset
It’s a superb, all-round Quality System Engineer career development role with a world leader in medical devices. So if this describes you and your aspirations, then please click on the APPLY button.
Primary Work LocationCHE Eysins - Business Park Terre-Bonne
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