Quality Assurance Engineer
Il y a 5 mois
**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 our story? Don't hesitate, come and join us
**About the Opportunity**
We are seeking a highly motivated Quality Assurance Engineer to join our growing Post-Market Surveillance team. In this role, you will play a vital part in ensuring the safety and effectiveness of our medical devices after they have been launched on the market. You will be responsible for monitoring device performance, analyzing data, identifying potential risks, and reporting these findings to regulatory authorities and the company.
**Job responsibilities**:
- Develop and implement a comprehensive plan for post-market surveillance activities, following regulatory requirements (MDR, MDSAP, FDA, etc.).
- Collect, review, and analyze post-market from various sources (customer complaint reports, regulatory agencies notifications, adverse event reports, clinical studies) to identify trends and potential safety issues.
- Perform risk analysis based on post-market data and other relevant information to assess product risks and propose adequate updates to the applicable documentation.
- Perform Health Hazard Evaluations (HHEs) and Health Risk Assessments (HRAs) per the internal procedures.
- Prepare reports summarizing findings and propose corrective actions, if necessary.
- Prepare post-market surveillance mandatory reports per the applicable regulations and standards.
- Collaborate with cross-functional teams (R&D, Quality Assurance) to understand device functionalities and potential failure modes.
- Stay up to date with regulatory guidelines and industry best practices for post-market surveillance.
- Develops and maintains process procedures and work instructions in a scope of continuous improvement.
**Qualifications**:
- Master's degree in biomedical engineering, mechanical engineering, or related field.
- Minimum of 3 years of experience in post-market surveillance, complaint handling, or related roles in the medical device industry.
- Strong understanding of regulatory requirements and standards governing medical devices, including Regulation (EU) 2017/745, MDSAP, FDA regulations and ISO 13485.
- Experience with complaint investigation and root cause analysis methodologies (e.g., 5whys, fishbone diagram, FMEA).
- Fluent in English, with excellent written and verbal communication skills.
- Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and communicate findings and recommendations.
- Ability to work independently and manage multiple projects simultaneously in a fast-paced environment.
- Experience with medical device risk management processes (e.g., ISO 14971) is preferred.
- Comfortable with Microsoft Office suite (e.g., Excel) and with any database software solutions.
Type d'emploi : Temps plein, CDI
Statut : Cadre
Avantages:
- Prise en charge du transport quotidien
Programmation:
- Du lundi au vendredi
- Travail en journée
Lieu du poste : En présentiel
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