Quality Assurance Specialist

QA/RA Engineer – Medical Devices (MDR) Location: Copenhagen area, Denmark (Industrivej 12, 3540 Lynge). Hybrid: remote work with on-site visits to Valcon typically once or twice a month. Candidates based elsewhere in the EU are welcome to apply. Application deadline: 30 November 2026. We are hiring as soon as possible, so applications are reviewed as received and the posting may close earlier once the position is filled. Do you have solid experience with quality assurance and regulatory affairs for medical devices under EU MDR 2017/745 and ISO 13485:2016, and are you motivated by the opportunity to build a QA/RA function from the ground up? Would you like to take ownership of technical documentation, risk management, and Notified Body compliance for a growing medical device portfolio? Then you might be our new QA Specialist. About Valcon Medical Valcon Medical A/S manufactures medical cannabis extracts and cannabis oils for the Danish market and a number of export markets. We are approved by the Danish Medicines Agency to manufacture medical cannabis in accordance with EU-GMP and applicable Danish legislation on medical cannabis. We are a company in development, with new products, processes, and technologies entering the organization, including an expanding medical device portfolio. This role is being established to build our QA/RA function for compliance with EU MDR 2017/745 and ISO 13485:2016, and to ensure our device documentation and processes meet Notified Body and Competent Authority expectations. You will work closely with colleagues across Quality, R&D, Manufacturing, and Clinical Affairs. As a smaller company, we have short decision-making paths, and the QA/RA function works closely with the rest of the organization. You will therefore have the opportunity to work with both classic QA/RA tasks and take responsibility for new issues, where you will independently investigate, assess, and help find the right solution, including shaping how our MDR compliance function is built from an early stage. Areas of responsibility for the QA/RA function

• Implementation, maintenance, and continuous improvement of the Quality Management System in compliance with ISO 13485:2016 and EU MDR 2017/745
• Maintain current knowledge of EU MDR 2017/745, ISO 13485:2016, and relevant harmonised standards, and advise the organization on compliance matters
• Preparation and maintenance of Technical Documentation (MDR Annex II/III), including GSPR checklist (Annex I) traceability to design and verification/validation evidence
• Document Control as a core, ongoing function: creation, revision, review/approval routing, distribution, and archival of controlled documents and records (ISO 13485:2016 Clauses 4.2.4/4.2.5)
• Change Control: assessment and impact evaluation across design, risk, and regulatory documentation, and approval routing for design, process, and document changes
• Risk management (ISO 14971) throughout the product lifecycle, including FMEA documentation and risk control/mitigation measures
• Review and approval of verification and validation protocols and reports, and support for validation of processes, software, and equipment (e.g. IEC 62304, as applicable to the product)
• Preparation and review of CAPAs and nonconformance reports
• Supplier qualification and ongoing oversight of critical suppliers, including Quality Assurance Agreements (ISO 13485:2016)
• Conduct supplier audits and support Notified Body audits under the MDR Annex IX conformity assessment procedure
• Post-Market Surveillance per MDR Articles 83–86, including complaint handling, PMS reporting, and PMCF as applicable
• Vigilance reporting to Competent Authorities per MDR Articles 87–92, including serious incident reporting and Field Safety Corrective Actions
• UDI assignment and EUDAMED registration activities (Basic UDI-DI, UDI-DI, device and certificate registration)
• Clinical Evaluation Report maintenance per MDR Article 61 / Annex XIV, in coordination with Clinical Affairs, where applicable
• Collaborate with R&D, Manufacturing, and Clinical Affairs to embed GSPR (Annex I) and Design Control (ISO 13485:2016 Clause 7.3) requirements into product development and production
• Provide training to employees on QMS requirements, EU MDR obligations, and risk-management practices
• Provide input on EU regulatory submissions and CE-marking compliance strategy, including engagement with Notified Bodies

Your qualifications and experience We envision that you have:

• A bachelor's degree in Engineering, Life Sciences, or a related field
• A minimum of 2–5 years of experience in QA/RA roles within the medical device industry, working under EU MDR 2017/745 and ISO 13485:2016
• Hands-on working experience inside a live, certified ISO 13485:2016 Quality Management System, not solely academic or classroom knowledge of the standard
• Direct, hands-on experience operating within core QMS processes: Supplier Control, Document Control, Change Control, Complaint Handling, and CAPA
• Working knowledge of ISO 13485:2016 and EU MDR 2017/745, and of relevant harmonised standards (e.g. ISO 14971, IEC 62366-1, IEC 60601 series, IEC 62304 as applicable to the product)
• Demonstrated, hands-on authorship or maintenance experience with EU MDR Technical Documentation (Annex II/III), including GSPR checklist mapping and design/verification/validation evidence linkage. General familiarity with the standard is not sufficient
• Ability to interpret and apply EU regulatory requirements effectively, including direct engagement with Notified Bodies
• Fluent English, written and spoken, for Notified Body and international supplier communication

It is an advantage, but not a requirement, to have experience with one or more of the following areas:

• EUDAMED, the UDI system, and Basic UDI-DI concepts
• EU GMP requirements, given Valcon's GMP-regulated production environment
• Danish language skills

Your competencies

• Works in a structured and systematic manner, with a focus on completing tasks
• Able to work independently, take responsibility for own tasks, and drive projects forward
• Strong grasp of risk management (ISO 14971) and verification/validation principles
• Enjoys a mix of technical assessment, practical problem-solving, and documentation work
• Is proactive, solution-oriented, and contributes positively to collaboration with colleagues
• Competencies in data processing and report writing

What we offer You will have a broad and independent role in a company in development, where you will help build our medical device QA/RA function from an early stage and work closely with production, product development, and the company's other activities. As part of a smaller organization, you will have short decision-making paths, extensive insight across the company, and the opportunity to have real influence on both your own areas of responsibility and the development of our QA/RA function. For the right person, there are good opportunities to develop the role as the company grows and to take responsibility for new subject areas and projects. This is a hybrid role. Most of the work can be done remotely, and we expect you on site at our facility in Lynge, north of Copenhagen, typically once or twice a month. Expect more frequent presence during onboarding and around Notified Body and supplier audits. [Travel costs to Valcon are covered by the company.] How to apply The position is based in our QA/RA function. If you would like to hear more about the job, please contact Chanel La (cl@valcon-medical.com) or Mike Sabatello (ms@valcon-medical.com), or call +1 312 985 6222. Please send your CV to job@valcon-medical.com. In your application, please include 3–4 sentences on a Technical Documentation or CAPA process you personally owned under a certified ISO 13485 QMS: what you did and what the outcome was. We look forward to hearing from you. Job Type: Full-time Pay: From 330.000,00kr. per year Application Question(s):

• In your application, please include 3–4 sentences on a Technical Documentation or CAPA process you personally owned under a certified ISO 13485 QMS: what you did and what the outcome was.

Education:

• Bachelor's (Required)

Experience:

• MDR Quality Assurance: 2 years (Required)

Work Location: In person