Head of Quality

4 weken geleden


Eindhoven, Nederland Salvia BioElectronics B.V Voltijd

Salvia BioElectronics is a medical device company pioneering neuromodulation therapies for migraine. Salvia's unique, paper-thin implant is designed to reduce the frequency and intensity of migraine attacks by delivering gentle electrical pulses to the nerves associated with the condition. The company is currently in the clinical stage of development. In addition, Salvia is considering potential opportunities the device creates for the treatment of cluster headache and other neurological disorders. Salvia has received the Breakthrough Device Designation from the United States Food and Drug Administration (FDA), which facilitates expedited market access for devices that treat life-threatening or irreversibly debilitating conditions.

The challenge

Salvia is committed to uphold high quality standards to ensure patient safety and business success. As Salvia’s Head of Quality, you play a pivotal role in ensuring that Salvia’s products meet rigorous quality standards and regulatory requirements. You oversee the further development and continuous improvement of our Quality System in compliance with relevant regulations. You closely collaborate with Salvia’s R&D and Operations teams to ensure Salvia’s products and processes comply with applicable standards and regulations. Working closely with your team and the various Process Owners, you develop training programs to ensure awareness and adherence to Salvia’s quality system procedures. As part of Salvia’s Leadership Team, you help shape the company’s strategic agenda and translate business ambitions into tangible goals and quality objectives. You report to the CEO.

Responsibilities

• Actively bolsters Salvia’s “quality belongs to everyone” policy.
• Builds and coaches a team of quality professionals that foster a company-wide learning environment to maintain the efficiency and effectiveness of Salvia’s Quality System processes.
• Ensures that Quality Engineering, Quality Assurance, and Quality Control are firmly embedded in the company’s product development projects, supply chain, and ongoing operational processes.
• Sets the vision of Quality System development in line with the company’s business strategy and organizational growth.
• Leads continuous improvement initiatives to enhance product quality, manufacturing processes, and overall operational efficiency.
• Ensures that the company’s products and operations comply with all applicable regulatory requirements and maintains knowledge of evolving standards and regulations.

Your profile

• Thorough understanding of regulatory requirements for medical devices and quality systems (FDA, MDR, ISO13485, etc), and familiarity with medical device design, manufacturing and testing.
• Attention to detail: precision and thoroughness in quality-related processes and documentation.
• Excellent communication skills and able to lead and inspire people across all levels.
• Strong analytical and problem-solving skills to address quality issues and compliance challenges.
• Champions a risk-based approach; strict where necessary yet mindful of resource constraints.

faces of Salvia

Will you be our new colleague?

Our team is growing and we are always looking for passionate and talented individuals who want to be part of our mission to give people with migraine a better life.

We encourage open applications. Please submit yours here

Acquisition is not appreciated.

You will join Salvia’s production team where your key responsibility will be to support and manage the various material and goods flows, including production consumables, components, subassemblies from external suppliers and finished goods.

With a focus on ongoing development, we are currently looking for a Clinical Trial Assistant. You will be part of the clinical team and able to work on clinical studies at various stages. The CTA is responsible for operational and administrative support throughout a clinical study.

With a focus on ongoing development, we are currently looking for a Clinical Research Associate. You will be part of the clinical team and able to work on clinical studies at various stages. The CRA plays a crucial role in ensuring the successful conduct of clinical trials by maintaining high standards of quality, compliance, and patient safety.

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