Quality Assurance Manager (Medical Devices) (m/w/d)

We are an innovative medical device start-up focused on cardiac surgery, developing a novel vein harvesting system to improve outcomes in coronary artery bypass grafting procedures. Having successfully completed proof-of-concepts, we are now in the critical phase of finalizing our product design, preparing for certification, and transferring the design to manufacturing. Located in the west of Vienna with excellent access to public transport via the U4 line, we offer a dynamic and collaborative work environment where cutting-edge technology and life-saving solutions come together. Join us in shaping the future of cardiac surgery and making a real impact on patients' lives.

Quality Assurance Manager (Medical Devices)

Full-time position in Vienna (m/f/d)

Role Overview

As the Quality Assurance Manager, you will take the lead in finalizing, implementing, and maintaining our QMS in compliance with ISO 13485 standards. Your role will be crucial in ensuring that our medical devices meet all regulatory and quality requirements. You will work closely with our Regulatory Affairs and Engineering team to drive product compliance from development through to certification.

Key Responsibilities

* Lead the finalization and full implementation of the QMS, ensuring compliance with ISO 13485, FDA 21 CFR 820, and EU MDR.
* Manage internal audits and support external audits to ensure regulatory compliance.
* Oversee risk management activities, ensuring adherence to ISO 14971.
* Collaborate with the Regulatory Affairs team to provide necessary quality documentation for CE marking and FDA approval.
* Ensure compliance with design control, validation, and verification processes for the vein harvesting system.
* Establish and monitor quality metrics, driving continuous improvement initiatives.
* Manage CAPA processes and ensure timely resolution of quality issues.
* Train and support staff in quality management processes and regulatory requirements.

Qualifications

* Bachelors degree in a relevant field; advanced degrees or professional certifications in Quality Assurance are highly desirable.
* Minimum of 5 years of experience in Quality Assurance in the medical device industry.
* Strong knowledge of ISO 13485, ISO 14971, and other regulatory frameworks (FDA, EU MDR).
* Experience with QMS implementation, including design controls, validation, and verification.
* Experience conducting internal and external audits and managing CAPAs.
* Fluency in English is required.
* Excellent communication skills with the ability to collaborate across teams.
* A proactive, problem-solving mindset focused on continuous improvement.
* Ability to work autonomously in a fast-paced, start-up environment.

What We Offer

* Competitive salary and benefits package.
* Flexible working hours and flexible remote work options to support work-life balance.
* Professional development opportunities and the chance to grow with the company.
* Convenient office location with excellent public transport connections (U4 line).
* The opportunity to work on life-saving technology in a high-impact role within a fast-growing start-up.
* A dynamic and collaborative environment where innovation and teamwork drive success.
* A supportive team culture with regular team events, fostering a strong sense of community.

How to Apply

If you are passionate about quality assurance and want to contribute to the development of life-saving medical technologies, we would love to hear from you! Please send your CV and a brief cover letter via smart apply.

We have set a minimum gross salary of EUR4,000 per month for this position. However, we are open to offering higher compensation based on your qualifications and experience.

Valeriot FlexCo
Dipl.-Ing. Dipl.-Ing. Michael Flatscher
office@valeriot.com
Elßlergasse 26/8
1130 Wien
Web: http://www.valeriot.com