Head of QA
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Kongens Lyngby
At MedTrace you will be a valued member of the team and take part in our exciting journey of bringing our innovative soft and hardware solution for heart patient diagnostics to market. The technology is ground breaking and is already now drawing international accreditation.
MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases.
MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility and dedication.
To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan.
The position as Head of QA
The position as Head of QA is new at MedTrace. You will get an exciting opportunity to exercise your knowledge within quality assurance in various different technical areas such as medical device, pharmaceuticals, hardware, software, etc..
You will take a leading role in all aspects of the continued work with developing and establishment of the ISO 13485:2016 compliant QMS covering both medical device as well as pharmaceutical manufacturing. As Head of QA your role is to lead the QA-processes towards certification as will be required for the regulatory clearance of MedTrace’s product. You will be stepping into the design and development phase of the MedTrace´s products, so being able to execute on tasks in an efficient manner is key to your success. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home. You will be expected to travel as part of the job, but only on an as needed basis to which you will have a large degree of input.
Profile
Your key responsibilities will be:
Solid QA Experience from a regulated production/Industrial environment
Your background can be diverse (candidate from relevant university education i.e. Cand Scient or Engineer. What is most important is your solid experience from bringing a Medical Device to the market and your experience working on a QMS and being responsible for the QA/QC function. If you also have experience with QMS from Pharmaceutical industry it would be an advantage but not a requirement You thrive in a role where you have operational tasks and you must have the personal traits and the desire to lead others in a team capacity, and have direct reports.
Other qualifications:
You thrive in the innovative environment that a development stage company can offer
Personal profile
You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and implement changes. You are a responsible person, and you excell in maintaining focus even in busy times. You are a trustworthy person and you value good collaborations.
Application
For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or [email protected]. We will evaluate applications on a running basis, but we need your application no later than February the 15th 2021.
You can apply here:
MedTrace’s technology platform is a combination of an automated hardware system that is able to produce, dose and inject 15O-water, a very short-lived radioactive version of regular water and a software solution that makes the clinician able to draw conclusions about blood flow. The technique has potential for use in other organs and for diagnostic use in other diseases.
MedTrace has offices in Lyngby, Denmark and affiliates in Boston and Uppsala. The company favours cross functional teamwork and hiring employees with diverse backgrounds. The company language is English. In MedTrace, all members are valued, we are all very dedicated and ambitious in reaching our common goals. Every day presents itself with plenty of exciting tasks, but we are high spirited with a good sense of HUMOR. The atmosphere is informal, and everybody in the team is heard. Our values include trust in each other, respect for people, responsibility and dedication.
To become a success at MedTrace it is important to have an entrepreneurial mindset with a pragmatic approach to manoeuvre in a young organisation. The targeted markets are Europe, the US and later on Japan.
The position as Head of QA
The position as Head of QA is new at MedTrace. You will get an exciting opportunity to exercise your knowledge within quality assurance in various different technical areas such as medical device, pharmaceuticals, hardware, software, etc..
You will take a leading role in all aspects of the continued work with developing and establishment of the ISO 13485:2016 compliant QMS covering both medical device as well as pharmaceutical manufacturing. As Head of QA your role is to lead the QA-processes towards certification as will be required for the regulatory clearance of MedTrace’s product. You will be stepping into the design and development phase of the MedTrace´s products, so being able to execute on tasks in an efficient manner is key to your success. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home. You will be expected to travel as part of the job, but only on an as needed basis to which you will have a large degree of input.
Profile
Your key responsibilities will be:
- Setting up and development of the QA function including driving the development and maintenance of the QMS system
- Drive expectations for quality
- Perform QA review of design control documentation
- Select, qualify, and perform Quality Agreements with Suppliers
- Coordinate and perform Internal Audits
- Define and document quality procedures
- Refine processes for Complaint Handling, CAPA and Change ControlWork cross-functionally to ensure compliant QMS across all functions of the company
Solid QA Experience from a regulated production/Industrial environment
Your background can be diverse (candidate from relevant university education i.e. Cand Scient or Engineer. What is most important is your solid experience from bringing a Medical Device to the market and your experience working on a QMS and being responsible for the QA/QC function. If you also have experience with QMS from Pharmaceutical industry it would be an advantage but not a requirement You thrive in a role where you have operational tasks and you must have the personal traits and the desire to lead others in a team capacity, and have direct reports.
Other qualifications:
- Thorough understanding of ISO 13485, IEC 62304, MDR 2017/745 and 21 CFR 820
- Proven track record within a QA role and cross functional collaboration
- Speaks and writes English fluently and profond IT skills in MS Office package
- Good understanding of Quality Risk Management
- Strong in oral as well as written communication capabilities and the ability to work independently
You thrive in the innovative environment that a development stage company can offer
Personal profile
You are a “doer”. The company pulse is intense, but together we can accomplish almost everything. You want to make a difference and have an impact, and you like to see your input and ideas transformed into action swiftly. As a person you can simplify things, find solutions, and implement changes. You are a responsible person, and you excell in maintaining focus even in busy times. You are a trustworthy person and you value good collaborations.
Application
For more information, please contact Lise Sønnersgaard, Recruitment manager at PharmaRelations, telephone +45 60981303 or [email protected]. We will evaluate applications on a running basis, but we need your application no later than February the 15th 2021.
You can apply here:
Information og data
Denne ledige stilling har jobtypen "Afdelingsleder", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 29.1.2021, 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.
- Afdelingsleder
- Kongens Lyngby
- Mandag den 15. februar 2021
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