Senior QA/RA Expert, Denmark
Key2Compliance is expanding and we need to replenish our specialist team with several talented senior QA/RA experts. Your skills will be part of what Key2Compliance offer our customers. You will be part of our team of both experts and generalists who help innovative companies to CE mark medical device and IVD products. Together, we can provide the best tailored advice to each unique client.
We are proud that our core value is Patient Safety. Since 1994, we’ve helped companies develop safe products that help people all over the world.
Join our team where we have great commitment and where you can develop in your area of expertise!
About the role
As a senior QA/RA Expert you will be part of our team of specialists that work with a wide variety of products within MedTech and IVD, as well as combination products. Apart from working with other members of the QA/RA team, you will also be able to collaborate with colleagues in the clinical development, training and Biocompability teams.
Each consultant usually has between 2-3 projects simultaneously with clients in the small to medium-sized segment. The assignments can often be managed from our office or from home, but at times require us to be on site. The assignments consist of everything from short-term projects to longer assignments, giving you an interesting variety in your daily work.
About you
We believe you are highly interested in learning new things and have the ability to adapt when the situation changes. You are well-structured, organized and analytic. You enjoy problem solving and thrive off challenges. You have strong communication skills both in Swedish and English and believe that teamwork and sharing knowledge leads to the best results.
Key duties
QMS
• Create customer customized QMS that complies to ISO 13485:2016, MDR/IVDR, QSR
• Update current QMS at customer
• Implement e-QMS software
GAP analysis
• Carry out GAP analyzes of QMS and Technical documentation regarding legislation and standards.
Revisions
• Carry out internal audits
• Conduct audits at contract manufacturers
• Participate in Notified Body audits
Staffing
•Act as Quality Manager, QA and RA, in short or long assignments
Technical files
• Support in development projects
• Risk management according to ISO 14971
• Compile technical files
• Maintaining contacts with Notified Bodies
Generally
• Carry out QA/RA workshops at customers
• Support during the Management review
• Support in the PMS process
• Conduct supplier evaluations
• Find effective QA/RA solutions
Authorities and Responsibilities
• Carry out your assignments based on a quote
• Report problems to the Director
Qualifications
Education Requirements/Certifications
• ISO 13485:2016
• Internal auditing
• MDR and/or IVDR
Required Knowledge/Skill
• Very good spoken and written English and Danish
• Thorough but pragmatic
• Solution oriented
• Positive
• Flexible
• Be able to quickly adapt to new social contexts and conditions
Experience Required
• At least 5 years’ experience as a QA, RA or Quality Manager at small or medium-sized medical device, IVD companies
Information and contact details
Place of employment: Copenhagen, Denmark
Scope: Full time
Questions: Please contact Director Medical Device QA Team, Åsa Möllby, asa.mollby@key2compliance.com
Other: We screen the applications and hold interviews continuously so please send your application as soon as possible.
We look forward to receiving your application!
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