Senior Quality Assurance Specialist
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Smørum
Do you want to be a member of a QA team that ensures that the Hearing Instrument Group in Demant complies with the ISO 13485:2016, MDSAP, MDR and FDA CFR 21 part 820?
We are looking for a candidate in our quality audit team, with some years of experience in quality, preferable in medical devices. A relevant master’s degree in engineering or natural science will also be of good use. Knowledge in ISO 13485, MDSAP, EU MDD/MDR, and FDA 21CFR part 820.
The impact you can make
You will be responsible for coordination and ensuring the compliance of our CAPA system and be the CAPA expert supporting across our worldwide organization. You will be the CAPA expert in our organization providing support across our organization and establish a change advisory board for the system.
You will also be responsible for our electronical system (EDMS) for our QMS with users worldwide. Planning and implementing the change advisory board of our EDMS system together with the business system owner will also be one of your responsibilities.
Joining Our team
You will be part of the Quality Assurance team, with 10 very engaged employees. Our team are placed partly in Smørum and partly in Stettin in Poland. The vacant position is located in Smørum. The role of our team is to support our global organization with QA knowledge. We conduct internal audits and host external audits/ inspections and are responsible for setting the quality direction for our company. We are responsible for QMS, Document Control, CAPA, Strategic Quality projects, internal and external audits.
As a part of the QA team, you may also be able to support both Quality and the organization with your knowledge on QA subjects. This includes:
The job requires a great deal of collaboration with other internal departments in our global organization.
Your profile and personal skills
We are looking for a person who thrives in a complex organization with multiple stakeholders and different organizational structures. You have a pragmatic way to demonstrate your broad knowledge of QA requirements and tools. You enjoy being part of a highly motivated and skilled team, and you view your own achievements as the team’s achievements We empower each other and together we creates value as a team in the organization.
Above all, we value your ability to work with a collaborative approach and build trust with others. You are an engaging communicator – verbally and in writing – and you work closely with people at all levels of the organization. You have good stakeholder management skills and can work across the business in multiple countries and cultures.
According to your colleagues, you hold a high level of integrity, and you have a curious and positive mindset. We value your willingness to collaborate with engaged colleagues as well as wanting to develop yourself. We appreciate a colleagues that work proactively and in correlation with our values. It is beneficial if you have experience in working with change advisory board or similar and have experience with Medical Device.
You will be traveling 5 - 10 days per year.
We always try to make a difference
Together with your engaged and skillful colleagues, you will be part of an environment built on trust and openness, where you will find a strong will to win. We are a growing international company, where everyone strives to ensure that customers find our products the most attractive on the market. You will become part of a work environment where flexible working conditions, knowledge-sharing and professional respect make it meaningful to go to work.
Want to join the team?
Kindly submit your application as soon as possible but no later than 21. May, 2023. We’re going to interview candidates on an ongoing basis. Please note that we only accept applications via our online recruitment system.
If you would like to know more about the position, you are welcome to contact Lone Eskildsen, Senior Director Quality Assurance via phone +45 3058 5885, e-mail [email protected].
We are looking forward to hearing from you.
We are looking for a candidate in our quality audit team, with some years of experience in quality, preferable in medical devices. A relevant master’s degree in engineering or natural science will also be of good use. Knowledge in ISO 13485, MDSAP, EU MDD/MDR, and FDA 21CFR part 820.
The impact you can make
You will be responsible for coordination and ensuring the compliance of our CAPA system and be the CAPA expert supporting across our worldwide organization. You will be the CAPA expert in our organization providing support across our organization and establish a change advisory board for the system.
You will also be responsible for our electronical system (EDMS) for our QMS with users worldwide. Planning and implementing the change advisory board of our EDMS system together with the business system owner will also be one of your responsibilities.
Joining Our team
You will be part of the Quality Assurance team, with 10 very engaged employees. Our team are placed partly in Smørum and partly in Stettin in Poland. The vacant position is located in Smørum. The role of our team is to support our global organization with QA knowledge. We conduct internal audits and host external audits/ inspections and are responsible for setting the quality direction for our company. We are responsible for QMS, Document Control, CAPA, Strategic Quality projects, internal and external audits.
As a part of the QA team, you may also be able to support both Quality and the organization with your knowledge on QA subjects. This includes:
- Perform internal audits
- Participate in external audits preferable as a quality guide or at the back office
- Be involved in ongoing improvement of our processes in QA
The job requires a great deal of collaboration with other internal departments in our global organization.
Your profile and personal skills
We are looking for a person who thrives in a complex organization with multiple stakeholders and different organizational structures. You have a pragmatic way to demonstrate your broad knowledge of QA requirements and tools. You enjoy being part of a highly motivated and skilled team, and you view your own achievements as the team’s achievements We empower each other and together we creates value as a team in the organization.
Above all, we value your ability to work with a collaborative approach and build trust with others. You are an engaging communicator – verbally and in writing – and you work closely with people at all levels of the organization. You have good stakeholder management skills and can work across the business in multiple countries and cultures.
According to your colleagues, you hold a high level of integrity, and you have a curious and positive mindset. We value your willingness to collaborate with engaged colleagues as well as wanting to develop yourself. We appreciate a colleagues that work proactively and in correlation with our values. It is beneficial if you have experience in working with change advisory board or similar and have experience with Medical Device.
You will be traveling 5 - 10 days per year.
We always try to make a difference
Together with your engaged and skillful colleagues, you will be part of an environment built on trust and openness, where you will find a strong will to win. We are a growing international company, where everyone strives to ensure that customers find our products the most attractive on the market. You will become part of a work environment where flexible working conditions, knowledge-sharing and professional respect make it meaningful to go to work.
Want to join the team?
Kindly submit your application as soon as possible but no later than 21. May, 2023. We’re going to interview candidates on an ongoing basis. Please note that we only accept applications via our online recruitment system.
If you would like to know more about the position, you are welcome to contact Lone Eskildsen, Senior Director Quality Assurance via phone +45 3058 5885, e-mail [email protected].
We are looking forward to hearing from you.
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 3.5.2023, 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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