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QA (Quality Affairs) Assistant - QMS

Note: This position is for maintaining quality and regulation QMS and is NOT for software quality assurance testers.

Neteera is developing a cutting edge and state-of-the-art radar-based technology, for remote and contactless vital sign sensing solution in the healthcare domain.

Our technology comprises unique innovative Radar-on chip in the sub-terahertz (THz) range, which together with appropriate algorithms allow the measurement of vital signs and behavioral parameters.

Neteera is looking for a dedicated QA Assistant for our quality systems management, with experience in the medical device industry, preferably including software components. Come grow with us. 

Key responsibilities and tasks:

  • Implement the quality management system and ensure that the company complies with standards and regulations such as FDA 21 CFR Part 820, ISO 13485, and IEC 62304 for medical devices with software components

  • Operate and maintain the QMS

  • Hands-on QA work: Document Control, CAPA, ECO, Supplier Control, Software Lifecycle, Training, etc.

  • Actively participate in QMS improvement initiatives, suggesting process enhancements and participating in cross-functional teams to drive change

Professional skills:

  • Proven experience in quality affairs for medical device company for at least 1 year

  • Knowledge of quality management principles, standards (ISO 13485), and regulations relevant to the organization's industry (FDA, EU MDR)

  • Experience with medical devices using Software (IEC 62304) – an advantage

Candidate Profile:

  • Proficiency in English

  • Attention to detail

  • Excellent communication and interpersonal skills

  • Proficiency in document management and office software (e.g., Microsoft Office, document control software)

If you have the necessary experience and qualifications for this position, we encourage you to apply.

Send your CV to:

hr@neteera.com

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