Supplier Quality Engineer

**About Balt**

Our purpose is to improve the lives of 150,000 patients in 2026.

**Our story**

Balt is a rapidly growing pioneer in an exceptional field. For 45 years, Balt has been leading the way - collaborating with physicians and institutions to develop elegant medical devices. Our products are being used by physicians across the world, and we have 13 offices in 11 countries - and counting.

We introduced one of the first neurovascular intervention devices in 1977 and now offer the world's broadest portfolio of medical devices for stroke. As the premier global neurovascular platform always seeking to expand beyond boundaries, we are now bringing our innovation to the peripheral vascular space.

We are proud of our mission, our people, and the incredible work we accomplish together as we empower physicians to save lives.

**Why Join Balt? Join a passionate team, dedicated to making a difference.**
- Working at Balt means giving meaning to your work Pride is a strong part of our identity.
- We are a close-knit team, with strong mission, vision and values that guide our day-to-day.
- Recognition of work, respect, and our multicultural community are key aspects of the employee experience and contribute to our continued success.
- No matter the country, we take care of you.

Would you like to be part of story? Don't hesitate and come and join us.

**About this opportunity**

Working in the Quality department, you will report to the QA Supplier manager in a dynamic, international environment. You will support the Purchasing and Quality Managers in defining and implementing the strategy and monitoring of OE quality and performance with the aim of moving towards a culture of operational excellence. You will be responsible for establishing and maintaining OE quality records and systems, ensuring compliance with Balt's quality systems and regulations.

**Job responsibilities**:

- Harmonize, develop, improve, and ensure alignment with economic operators quality standards to meet the requirements of MDR regulations (procedures, tools, training)
- Evaluate and monitor economic operators within the framework of quality standards
- Develop tools and action plans, manage and improve the operational performance (logistics and quality) of economic operators

**Operational management of economic operators**
- Be SME for CAPA set up to improve the management of economic operators
- Develop quality standards to meet quality and regulatory requirements
- Implement quality contracts and agreements
- Align processes, systems, tools and procedures in collaboration with the various Balt sites
- Participate in the qualification of EO and maintain the list of approved EO
- Lead and coordinate the annual assessment of EO (monitoring)
- Lead the preparation and participate in the annual management review
- Participate in the problem-solving plan
- Participate in the conduct/coordination of EO audits; review audit results and take corrective action against EO, as appropriate
- Participate in Balt's internal and external audits as SME

***Supplier management**
- Act as a back-up to the Supplier Quality Manager and provide support in the operational management of suppliers

**Qualification requirements**:

- 5 years higher education (minimum 4 years’ experience) or 2 years higher education with significant experience in an international, cross-functional context
- Knowledge of requirements and standards applicable to medical devices or pharmaceutical products
- Fluent in English: possibility of international travel
- Ability to write reports, coordinate cross-functional issues and communicate effectively
- Auditing experience, auditor certification is a must
- Working knowledge of 21 CFR Part 820, ISO 13485, MDD and MDR standards for medical device manufacturing environments

L1-KN1