Are you looking for a purposeful next step in your QA career? Visiopharm aims to solve some of the world's most exciting machine learning challenges for tissue-based cancer research and diagnostics. We are on a mission to make sure that no patient gets the wrong treatment due to suboptimal tissue-based information that is used by doctors to make life saving decisions for patients. That’s great purpose!
Do you have quality skills and experience and are you eager to become part of a small but hugely professional (and fun!) Quality and Regulatory Affairs team? Are you serviceminded and structured, do you have administrative flair, do you know the requirements in ISO13485:2016 and IVDR, and do you love working with people cross borders and with many different tasks during a normal workday? Then read on – we might be what you are looking for!
About us:
Visiopharm is a mid-sized MedTech company that specializes in transforming pathology through AI-based tissue analysis and standardization. We empower scientists and pathologists with AI-driven precision pathology software for research and diagnostics, including tools for tissue-based research, IVDR compliant algorithms, and quality control for standardization of tissue biomarker staining.
We are grounded in Danish work ethics with an open and informal atmosphere. As a company we are ISO 13485:2016 certified and we have achieved certification under the European In Vitro Diagnostic Regulation (EU IVDR). This creates the exciting framework for the tasks, roles, and responsibilities for our Quality and Regulatory Affairs team.
The Quality site of the Quality and Regulatory Affairs team has the responsibility of driving Quality processes, keeping the QMS in compliance with the requirements and maintain and pursue applicable certifications.
About the role:
As a Quality Assistant you will play a key role in identifying requirements, ensuring requirements are incorporated in the QMS in a simple and effective way, prepare and perform internal audits of the QMS against requirements and participate in organizing and taking part in inspections by authorities. As our Quality Assistant and part of the team, you will also participate in creating and implementing new and efficient ways of working in the Quality and Regulatory Affairs team.
Your key responsibilities:
• Maintain and support optimization of the Quality Management System (QMS) according to ISO 13485:2016 and IVDR requirements.
• Take the lead on conducting NCs, CAPAs and CRs
• Plan and perform internal audits and participate in internal and external audits
• Prepare and conduct Management Reviews
• Manage suppliers and economic operators
• Lead the validation of equipment, processes and software
Preferred requirements:
• Bachelor’s degree, preferably in natural science
• Experience within quality management of medical devices, preferably devices including software
• Familiarity with ISO 13485 and IVDR (2017/746)
• General proficiency in software
• Experience with internal and/or external audits
• Fluent in English, both written and verbal
What makes you a great fit:
• You thrive in collaborative, international environments
• You are a pragmatic person with an open and communicative approach, inspired to find new and smart ways to fulfil quality requirements
• You appreciate a balance of autonomy and teamwork
• You're driven by making a meaningful impact in healthcare
• You bring a positive attitude to an already informal and humorous team
• You can collaborate closely with team members
What we offer:
• A workplace with an international perspective, a broad and diverse customer base, and close relations with biopharmaceutical companies and medical hospitals
• A modern workplace that values work-life balance
• A dynamic work environment with a dedicated team
• Ongoing opportunities for professional development
• Competitive compensation package and benefits including pension, medical insurance and catered lunches
Location and reporting lines:
You will be working from our office in Hørsholm – just North of Copenhagen, Denmark, however we offer hybrid working.
You will be reporting directly to the Manager of Quality and Regulatory Affairs, which is a department under our CTO and co-founder Johan Doré.
What’s next?
If you believe this job is the right fit for you and that you are the right fit for us, please send your application and CV by March 12th.
We will be conducting interviews on a rolling basis and look forward to meeting you.
If you have any questions about the role, feel free to reach out to hiring manager Rebekka Luise Löffler via rll@visiopharm.com or tel. +45 91 89 22 40.
Should you have any special requirements for the interview, please let the hiring manager know upon accepting invitation to interview.
