QA Operations
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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 QA Operations
The position as QA Operationsis 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..
The company has been working on the development of a QMS covering both 1) medical device and 2) pharmaceutical manufacturing equipment (scope of products). The QA Operations is expected to assist the Head of QA in the further establishment of the QMS and hereunder assist the process towards certification as will be required for the regulatory clearance of the Company’s products. In addition, the QA Operations will take a lead role in daily operational compliance tasks such as:
The job function has a cross-organizational reach to both sales, development, service etc. but the employee is expected to be self-driven, i.e. the QA Operations is expected to take own initiatives within the scope of the job description and properly align initiatives with the Head of QA.
The job as QA Operations is full-time. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home.
Background
Your background is M. Sc. in the life science field or equivalent/relevant education. Ideally you have 1-3 years of work experience with quality assurance and/or compliance as well as knowledge og GMP and medical devices. Preferably you have experience with Quality Management systems, i.e., D4Infonet. You are experienced with Standard Operating Procedures and ISO 13485 is also among your knowledge. You also have knowledge of pharmaceutical legislation and GMP.
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 work collaborative. You are a responsible person, and you excel in maintaining focus even in busy times. You are a trustworthy person, and you value to get things done to a high quality level.
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 June the 14th 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 QA Operations
The position as QA Operationsis 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..
The company has been working on the development of a QMS covering both 1) medical device and 2) pharmaceutical manufacturing equipment (scope of products). The QA Operations is expected to assist the Head of QA in the further establishment of the QMS and hereunder assist the process towards certification as will be required for the regulatory clearance of the Company’s products. In addition, the QA Operations will take a lead role in daily operational compliance tasks such as:
- Order handling
- Complaint handling
- Non-conformities
- Review of batch documentation from suppliers
- Procedure updates
- CAPA work
- Other QMS and compliance related tasks
- Projects related to operations and product life cycle and maintenance
The job function has a cross-organizational reach to both sales, development, service etc. but the employee is expected to be self-driven, i.e. the QA Operations is expected to take own initiatives within the scope of the job description and properly align initiatives with the Head of QA.
The job as QA Operations is full-time. Your main base of operation will be at head office in Lyngby Copenhagen, and MedTrace is flexible towards working from home.
Background
Your background is M. Sc. in the life science field or equivalent/relevant education. Ideally you have 1-3 years of work experience with quality assurance and/or compliance as well as knowledge og GMP and medical devices. Preferably you have experience with Quality Management systems, i.e., D4Infonet. You are experienced with Standard Operating Procedures and ISO 13485 is also among your knowledge. You also have knowledge of pharmaceutical legislation and GMP.
Other qualifications:
- Strong in collaborative thinking and capability
- Able to work independently
- Proven track record within a QA role and cross functional collaboration
- Speaks and writes English fluently and profound IT skills in MS Office package
- Good understanding of Quality Management
- Strong in oral as well as written communication capabilities
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 work collaborative. You are a responsible person, and you excel in maintaining focus even in busy times. You are a trustworthy person, and you value to get things done to a high quality level.
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 June the 14th 2021.
You can apply here:
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Kongens Lyngby.
Jobbet er oprettet på vores service den 28.5.2021, 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.
- Øvrige
- Kongens Lyngby
- Onsdag den 16. juni 2021
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