Sr. QA Specialist

Job description

You are methodical and thrive when you are given a high level of autonomy, responsibility, and purpose. For you, the success of the team and the products is paramount and you strive to continually improve.

MedTrace is looking for Senior QA Specialist to be part of our Quality Assurance team supporting all functions and activities within MedTrace.

Our products cover medical devices including Software and pharmaceutical manufacturing equipment as well as the radioactive drug product. MedTrace is dedicated to becoming a global leader in perfusion imaging. Our products are under development and are being designed to help patients be diagnosed quickly and accurately. We are growing rapidly, backed by strong investors such as ATP, BankInvest, Swisscanto, Private Equity, and the European Innovation Council.

You will be part of a QA team handling a wide variety of tasks related to running production, regulatory approvals, supplier handling and daily operations. This role is intended to strengthen the QA team further ensuring strong support throughout MedTrace. Focusing on supplier auditing, daily operations and drug product support.

Your personal values include drive, a passion for your work, responsibility, and a commitment to diversity and equality. You enjoy a working environment that is dynamic and versatile.

When applying for this position, please submit both a cover letter and a CV in order to be considered.

Key responsibilities:

• Plan, conduct, and report supplier and GCP audits to verify compliance with applicable regulations and company standards;

• Maintain and improve the QMS to ensure alignment with 21CFR, Eudralex, ISO 13485, and GCP standards;

• Review and approve non-conformities, change controls, CAPAs, and controlled documents.

You:

• Are driven, trustworthy, pragmatic and service minded;

• Possess great communication and collaboration skills;

• Want the entire QA team to be successful;

• Possess excellent documentation and writing skills.

You thrive in an organization that includes diverse cultures and people at all organizational levels, and you are excited about the opportunity to be part of a scale-up company and help shape its future.

Requirements:

At least one of the following is true of you:

• You have earned a Bachelor´s or Master’s degree in Life Sciences, Pharmacy, or Engineering.

• You have minimum 5 years of experience as Quality Assurance within the pharmaceutical, radiopharmaceutical, or medical device industry.

Furthermore:

• You have some experience in supplier auditing, CAPA, NC, CR, Complaint handling and SOPs writing and approving.

• You live in the greater Copenhagen area.

• You are fluent in written and spoken English.

It is bonus if you have experience with any of the following:

• Eudralex

• GCP

• D4 InfoNet

We look forward to hearing from you! 

Our corporate language is English.