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Quality Assurance Engineer

Stentit BV | Eindhoven | NL

Welcome to the Latest Job Vacancies Site 2025 and at this time we would like to inform you of the Latest Job Vacancies from the Stentit BV with the position of Quality Assurance Engineer - Stentit BV which was opened this.

If this job matches your qualifications, please send your application directly through our latest Job site. Indeed, every job is not easy to apply because it must meet several qualifications and requirements that we must meet in accordance with the standard criteria of the Company who are looking for potential candidates to work. Good job information Quality Assurance Engineer - Stentit BV below matches your qualifications.

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STENTiT is a medical device startup based at the High Tech Campus in Eindhoven, Netherlands, with the aim is to help people suffering from cardiovascular issues. We develop a novel class of regenerative endovascular implants for the treatment of cardiovascular diseases. Our ultimate goal is to restore the affected blood vessel from the inside out to provide a lifelong solution

Now we are looking for our Quality Assurance Engineer at our Eindhoven headquarters.

This is a unique opportunity for an ambitious, multi-talented individual who wants to see the inside of a fast-moving startup and shape the development of this first-of-a-kind medical device.

You will get insights into a unique company that has the vision to become one of the worlds leading players in regenerative endovascular implants.

You will be responsible for ensuring the quality compliance of devices according to the applicable laws, regulations, standards, and guidance. You will establish and implement a quality system to support development and manufacturing of an implant within the company (most of the manufacturing process occurs on-site in a newly build cleanroom). The position can be part-time.

Tasks

  • Develop and Maintain Harmonized Quality Management System (QMS) in compliance with ISO 13485, requirements
  • Keep up to date with regard to developments in the sphere of quality control and advise about quality actions
  • Guarantee Risk Management tasks are performed according to company’s expectation
  • Ensure that the process of internal and external audits are in place on a timely manner
  • Support suppliers to ensure that their products and services meet quality standards and specifications
  • Responsible for creating and finalizing the CAPA system and setting the CAPA policy
  • Management of Design History File (DHF) and Device Master Record (DMR) in accordance with US and European regulatory requirements
  • Collaborate with relevant departments within the company (primarily R&D and engineering) to develop manufacturing documentation, including work instructions and production records
  • Close collaboration with the Regulatory Department to ensure compliance to ISO14155, ICH-GCP, Medical Device Regulation, and other applicable national or international requirements
  • Support QC processes
  • Conduct employee training
Requirements

  • Master or PhD in Engineering or scientific degree - mandatory.
  • At least 5-10 years of experience in Quality Assurance in a MedTech company, preferably a MedTech company with own manufacturing facilities - mandatory.
  • Experience in develop and maintain harmonized Quality System in compliance with ISO 13485 - Mandatory
  • Familiarity with statistical methods, risk management, root cause analysis, and process validation - an advantage.
  • Experience in quality audits and employee training - an advantage.
  • Experience working in clean room environments - an advantage.
  • Knowledge on regulatory requirements such as ISO14155, ICH-GCP, Medical Device Regulation, technical documentation requirements, and other national and international requirements. - an advantage
  • Knowledge of regulatory submissions and requirements - an advantage.
  • Ability to work in a dynamic and multitasking environment.
  • Data processing and analysis skills.
  • Excellent communication skills in Dutch and English.
Benefits

  • Great opportunities for personal and professional growth in a committed, innovative and dynamic team.
  • Challenging and varied tasks in an innovative environment with real impact.
  • Experience entrepreneurship first hand.
  • Rare opportunity to actively shape the development of a first-of-a-kind medical product to safe patient lives.
Sounds interesting? We look forward to meeting you. Submit your CV and all relevant working documents online now!

Information :

  • Company : Stentit BV
  • Position : Quality Assurance Engineer
  • Location : Eindhoven
  • Country : NL

How to Submit an Application:

After reading and knowing the criteria and minimum requirements for qualifications that have been explained from the Quality Assurance Engineer job info - Stentit BV Eindhoven above, thus jobseekers who feel they have not met the requirements including education, age, etc. and really feel interested in the latest job vacancies Quality Assurance Engineer job info - Stentit BV Eindhoven in 2025-01-24 above, should as soon as possible complete and compile a job application file such as a job application letter, CV or curriculum vitae, FC diploma and transcripts and other supplements as described above, in order to register and take part in the admission selection for new employees in the company referred to, sent via the Next Page link below.

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Post Date : 2025-01-24

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