CAPA Coordinator

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.

Job Description:

• Interacts with all internal business areas connected to Products and Services
• Uses the internal control of documents system(Knowledge)
• Supports CAPA activities with external business partners
• Ensures compliance to CAPA processes and procedures
• Works as a liaise with relevant functional groups, facilitates and mentors teams through all stages of the CAPA processes
• Ensures users provide necessary rigor to the CAPA system content
• Monitors the progress of CAPA activities, ensuring that timelines are met, actions are completed, and CAPA status is updated in the CAPA documentation.
• Collaborates on the generation of CAPA reports
• Supports QMS improvement initiatives
• Works as a back up for the QMS Documentation Specialist, in cases of holidays or medical leave

Professional experience & skills desired to have:

• Completed studies in a relevant field such as engineering or life science
• Expert knowledge in quality management and CAPA principles
• Experience with Quality and Regulatory requirements in the medical device or life science industry
• Analytical skills to identify problems, develop and track solutions
• Problem-solving and root cause analysis techniques.
• Excel knowledge
• Excellent project management and organizational skills.
• Communication and teamwork skills for working with different departments
• Self-responsible, motivated, analytical personality
• Fluency in English and ability to write documents confidently in English
• German language is a plus

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.