- Full-time
- On-site / Hybrid
Head of Quality Assurance
This is not a documentation role. It is the quality-conscience seat in a Class IIb surgical robotics company at commercial inflection.
Sentante is building a robotic platform for endovascular procedures — a CE-marked Class IIb system with single-use sterile cassettes — now entering commercial launch in Europe and preparing FDA 510(k) entry in the United States. As Head of Quality Assurance, you are the company's product release authority and quality enforcement lead: you own the release decision, the non-conformance disposition, and the quality gates that R&D and Manufacturing must pass.
The role reports to the Head of QA/RA and carries a written independence mandate. First commercial installations, the production ramp of sterile disposables and the FDA submission cycle all depend on independent quality judgment applied daily on the floor — by someone with the technical depth to argue with engineers and the backbone to hold the line.
Key
responsibilities
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Product Release Authority
Final release sign-off for Sentante systems and sterile disposables. You review the Device History Record and the quality control data generated by Manufacturing, and you make the release, hold and quarantine decisions — including sterile-barrier and sterilisation release documentation — across all product configurations. -
Non-Conformance & CAPA
Full disposition authority over non-conforming product: use-as-is, rework or scrap, always with documented rationale. You chair the CAPA board and hold the organization to root-cause discipline, clear corrective action ownership and real effectiveness verification. -
Design Transfer Gate
No design moves into production without your sign-off on transfer readiness. Working with the Design Assurance Lead, you verify that the design, the documentation and the process are genuinely ready for manufacturing — not merely scheduled to be. -
Change Control & Process Approval
No production process change happens without quality approval. You hold a standing seat at design reviews and on the change control board, and you assess the quality impact of every proposed change before it reaches the floor. -
Supplier Quality
Approve, conditionally approve or disqualify suppliers on quality grounds, in coordination with the Manufacturing Quality Lead and Procurement — with the authority to say no when the data does not support the decision. -
Enforcement & Escalation
Raise quality issues in writing, with data, deadlines and consequences. Where quality judgment is challenged or overridden, escalate to the Head of QA/RA and, when necessary, directly to the CEO. The mandate is written into our quality manual and into this role's terms.
Required skills
5–10 years in medical device quality, including a substantial period in Class IIb/III active devices. Electromechanical systems and sterile disposables are strongly preferred; surgical, interventional or robotic device experience is ideal.
You have personally held and used product release authority. In the interview we will ask you to walk us through a shipment you blocked — the data behind it, the pressure you were under, and how it was resolved.
Deep working command of DHR and batch release, non-conformance and CAPA root-cause methodology, design controls (enough to challenge R&D on DHF completeness and transfer readiness), process validation (IQ/OQ/PQ), and sampling and statistical techniques.
Hands-on front-room experience with a Notified Body under ISO 13485 and EU MDR. FDA inspection experience is a strong advantage.
Peer-level technical credibility with engineers — you cannot be dismissed as "the compliance person". A documented escalation habit rather than hallway diplomacy. Engineering and manufacturing leaders should leave an argument with you annoyed, but unable to say you were wrong.
Perks & benefits
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Competitive Salary
4200-5600 Eur/month before taxes, with the final amount depending on the candidate’s qualifications and experience. We offer a competitive salary that is regularly reviewed to ensure fairness and alignment with market standards.
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Flexible Work Environment
We provide adaptable working hours and a supportive team culture, allowing you to manage your schedule effectively while working closely with colleagues in the office.
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Employee Wellness Program
On your birthday, you can choose between a day-off or an alternative wellness perk, such as access to the on-site SPA or wellness coupons.
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Paid Time Off
We offer a benefit that includes a paid day off on your birthday, giving you time to celebrate or enjoy the day as you wish. We also provide two additional paid days that can be used whenever needed, with no questions asked, to support flexibility, personal needs, and a healthy work–life balance.
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Professional Development
We support professional development by providing opportunities to learn, grow, and expand your skills. This includes hands-on experience, knowledge sharing within the team, and support for continuous learning as you grow in your role and take on new challenges.
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Team Buildings & Office Perks
Company-wide Summer & Winter events, holiday celebrations, and ongoing engagement activities. In-office perks including seasonal treats, fresh fruit, snacks, and sponsored lunch days.
Ready to join?
