Location Vienna, Austria (13th district – excellent U4 subway access)
Start Date: As soon as possible
Languages: Fluent English required
About Us
We are an innovative medical device startup in the field of cardiac surgery, developing a novel vein harvesting system to improve outcomes in coronary artery bypass grafting (CABG). Following successful proof-of-concept phases, we are now entering a demanding and exciting phase: preparing for regulatory certification, transferring our design into manufacturing, and scaling our operations.
Located in western Vienna with outstanding public transport connections via the U4 line, we provide a hands-on, collaborative environment where quality, regulatory, engineering, and management work closely together to bring life-saving technology to patients.
Role Overview
As a Quality Management Specialist, you will play a key operative role in executing and maintaining our ISO 13485-compliant Quality Management System (QMS).
Working closely with our experienced Regulatory Affairs & Quality Manager, you will take ownership of core quality processes and documentation while coordinating with R&D, suppliers, and manufacturing teams. Your contributions will directly support audit readiness, regulatory compliance, and successful certification. This position is ideal for an early-career quality professional with 2+ years of experience who thrives in structured, responsible work with visible impact in a small medical device organization.
Key Responsibilities
- Operate and maintain the QMS in accordance with ISO 13485 and applicable regulations (e.g., MDR)
- Manage quality documentation and records, including SOPs, forms, training records, and document control
- Independently track and document CAPAs, nonconformances, deviations, and change control activities
- Coordinate with internal stakeholders on risk management files, supplier quality assessments, and purchasing documentation
- Maintain production quality records, including inspections, nonconformance handling, and traceability
- Prepare for and support internal audits, management reviews, and external audits/inspections
- Assist with complaint handling, post-market surveillance, and continuous improvement initiatives
Qualifications
- Bachelor’s or Master’s degree in a relevant field (e.g., life sciences, biomedical engineering, quality management)
- 2+ years of hands-on experience in quality management in a regulated environment (medical devices preferred; pharmaceuticals or biotech acceptable)
- Practical knowledge of ISO 13485 and QMS principles
- Experience with structured QMS documentation and records
- Exposure to CAPA, change control, audits, or supplier quality processes is an advantage
- Structured, detail-oriented working style with strong sense of responsibility
- Ability to work independently on operative tasks while collaborating closely with the Regulatory Affairs & Quality Manager
- Fluent English (written and spoken); German language skills are an advantage
What We Offer
- A responsible operative role with direct involvement in certification and audit activities
- Close guidance and collaboration with an experienced Regulatory Affairs & Quality Manager
- Flexible working hours and hybrid/remote work options
- Professional growth opportunities as the company advances through certification and market entry
- Convenient office location with direct U4 subway access
- The chance to work on life-saving cardiac technology in a focused, supportive startup team
Details about this job
Full Time (Permanent employment)
- Monday to Friday
- 40 hours
Place of work
- Wien 13. Bezirk (Hietzing)
Must-have skills
- ISO 13485
- Medical Device Regulations
- Risk Management
- Quality Assurance
- CAPA
Required languages
- English C1
Details about this job
Full Time (Permanent employment)
- Monday to Friday
- 40 hours
Place of work
- Wien 13. Bezirk (Hietzing)
Must-have skills
- ISO 13485
- Medical Device Regulations
- Risk Management
- Quality Assurance
- CAPA
Required languages
- English C1
Salary
The actual minimum salary is 3,500 € gross per month (on a 40-hour basis), the actual salary depends on your qualifications and experience. The salary is paid 14 times per year.
All infos regarding your application
Required application documents:
- Cover letter
- Résumé
