Senior QA engineer
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Smørum
Do you want to work on a product that makes real impact on its users?
Would you like to change the life of people with a hearing loss by developing a mobile healthcare application?
Then you may be the Senior QA Engineer we are looking for!
You can be a part of our success by joining our QA team in Smørum as Senior Quality Assurrance Engineer and help people with hearing loss, by bringing our leading hearing health care solutions to the market. You will work in a growing international company in the medical-technical industry with many opportunities for professional and personal development. You will be part of a dynamic environment built on trust, openness and a strong will to win.
The area
In the role as of Senior QA Engineer, you will become a part of a team of 12 dedicated team members The main activities of the Quality Assurance team are documentation control, CAPA Process, QMS updates and maintenance, calibration process, and planning and execution of internal/external audits in relevant sites. The team is located both in Denmark and Poland.
You will be part of enabling our customers to get the most benefit out of our hearing aids. We are looking for an experienced tester, who will join our team working on the testing of a cross-platform mobile app for Android and iOS devices. The application is an innovative solution allowing tele-medicine and remote control of hearing aids. The quality assurance process is highly developed (medical industry) and there is a strong focus on test automation.
Responsibilities
• Responsible for ensuring the compliance of the CAPA process.
• Provide support across the organization in the CAPA process.
• Provide CAPA reports and conduct CAPA Board meetings.
• Conduct CAPA training. Develop and update the teaching material used.
• Administration of CAPA system
• Provide support across organization with Electronic Document Management System - Aras
• Provide support across organization with update of SOPs, Instructions and templates
• Provide support across organization with project related document control
• Participate in Internal and external audits.
Our requirements
You probably have a technical or commercial/business degree, but your experience is more important to us. Ideally you have minimum 3 years’ experience with working within CAPAs and QMS.
As a Medical Device manufacturer, we are looking for solid compliance and regulation knowledge within ISO 13485, Medical Device Regulation (MDR), and MDSAP.
Why apply…
You get to join a major company in its field and an organization with international footprint. We provide a collaborative and inclusive work environment and the opportunity to make a significant impact on the commercial growth of our organization.
Get in touch
Please send your CV and motivational letter as soon as possible, as we are screening applications on a continuous basis. Please note that we only accept applications through our online recruitment system.
Deadline for applications: 2nd february 2025.
If you have any questions regarding the position, you are very welcome to write Susanne Bach Schmidt (succ@.com)
At we value diversity, equity and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from all qualified candidates regardless of ethnic background, personality, age, gender, and education. Diversity is part of our cultural DNA. Women in STEM areas are particularly encouraged to apply, as supports United Nations Sustainable Development Goal 5 on gender equality.
Would you like to change the life of people with a hearing loss by developing a mobile healthcare application?
Then you may be the Senior QA Engineer we are looking for!
You can be a part of our success by joining our QA team in Smørum as Senior Quality Assurrance Engineer and help people with hearing loss, by bringing our leading hearing health care solutions to the market. You will work in a growing international company in the medical-technical industry with many opportunities for professional and personal development. You will be part of a dynamic environment built on trust, openness and a strong will to win.
The area
In the role as of Senior QA Engineer, you will become a part of a team of 12 dedicated team members The main activities of the Quality Assurance team are documentation control, CAPA Process, QMS updates and maintenance, calibration process, and planning and execution of internal/external audits in relevant sites. The team is located both in Denmark and Poland.
You will be part of enabling our customers to get the most benefit out of our hearing aids. We are looking for an experienced tester, who will join our team working on the testing of a cross-platform mobile app for Android and iOS devices. The application is an innovative solution allowing tele-medicine and remote control of hearing aids. The quality assurance process is highly developed (medical industry) and there is a strong focus on test automation.
Responsibilities
• Responsible for ensuring the compliance of the CAPA process.
• Provide support across the organization in the CAPA process.
• Provide CAPA reports and conduct CAPA Board meetings.
• Conduct CAPA training. Develop and update the teaching material used.
• Administration of CAPA system
• Provide support across organization with Electronic Document Management System - Aras
• Provide support across organization with update of SOPs, Instructions and templates
• Provide support across organization with project related document control
• Participate in Internal and external audits.
Our requirements
You probably have a technical or commercial/business degree, but your experience is more important to us. Ideally you have minimum 3 years’ experience with working within CAPAs and QMS.
As a Medical Device manufacturer, we are looking for solid compliance and regulation knowledge within ISO 13485, Medical Device Regulation (MDR), and MDSAP.
Why apply…
You get to join a major company in its field and an organization with international footprint. We provide a collaborative and inclusive work environment and the opportunity to make a significant impact on the commercial growth of our organization.
Get in touch
Please send your CV and motivational letter as soon as possible, as we are screening applications on a continuous basis. Please note that we only accept applications through our online recruitment system.
Deadline for applications: 2nd february 2025.
If you have any questions regarding the position, you are very welcome to write Susanne Bach Schmidt (succ@.com)
At we value diversity, equity and inclusion (DE&I) and we are committed to creating an inclusive working environment. We welcome applications from all qualified candidates regardless of ethnic background, personality, age, gender, and education. Diversity is part of our cultural DNA. Women in STEM areas are particularly encouraged to apply, as supports United Nations Sustainable Development Goal 5 on gender equality.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Smørum.
Jobbet er oprettet på vores service den 17.1.2025, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Smørum
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