Vigilance Specialist

True to the vision “We drive innovation to improve people’s lives”, the Hamilton companies have been providing solutions for the health sector since 1950. We are an innovative pioneer in the fields of ventilators, automated pipetting, sample management and in the development of process sensors.

Hamilton Medical is a leading manufacturer of intelligent ventilators. Whether in ICUs, during emergency rescue transport or an MRI scan – our solutions cover a multitude of patient groups, applications and environments.

Job Description:

• Have expert knowledge of Quality and Vigilance
• Coordinate activities in the internal handling of non-conforming products, in particular cause analyses and action plans and product deviation
• Coordinate activities in the case of external complaints, in particular root cause analyses and action plans
• Coordinate with suppliers in case of quality deviations
• Collaborate in improvement and development projects
• Support in the interpretation and implementation of regulatory requirements and support in risk analysis process
• Support for internal and external audits record and report quality key figures, e.g. by means of SPC
• Provide and conduct training in the area of quality

Professional experience & skills desired to have:

• Advanced knowledge of EU-MDR 2017/745, FDA 21CFR803
• Good knowledge about MDSAP requirements and ISO 13485 (IEC 60601 is a plus)
• Minimum 2 years of experience with reporting activities in the field of medical devices
• You are fluent in English and can write documents confidently in English.
• German language is a plus
• Good communication and problem-solving skills
• Willing to be curious and to learn
• Self-responsible, flexible, personal motivation, and analytical
• Ability to set up priorities and acting in a timely manner

How to apply:

Send us your resume at jobs.hce.ro@hamilton-ce.com or via the "Apply" button below.

Obtain more information via telephone +40356 635 056 / +40725 707 005

Only suitable candidates will be contacted for interview. Please note that your resume will be entered in our database and may be used in further recruitment projects.