QMS Specialist

Demant Polska; France; Hybride; EUR 55 000 - 75 000; Plein temps

Résumé du poste

Oticon Medical in Vallauris, France is seeking a QMS Specialist to support and maintain the Global Quality Management System and ensure regulatory compliance for medical devices.

Reporting to the QA Manager, you will drive improvements, audits, CAPA, training, and cross-functional collaboration to uphold ISO 13485 and MDR standards.

Qualifications

• Bachelor’s degree or higher in engineering, life sciences, or related field.
• Minimum 3–5 years of experience in Quality Assurance or Regulatory Affairs, preferably within medical devices or pharmaceutical industry.
• Good understanding of quality systems and regulatory standards.
• Structured, detail-oriented, and proactive approach.
• Strong communication, leadership, teamwork skills, and solution-oriented mindset.

Responsabilités

• Support the maintenance and continuous improvement of the Global Quality Management System (QMS).
• Ensure compliance with applicable regulatory requirements (ISO 13485, MDSAP, MDR 2017/745).
• Review and update QMS procedures and documentation.
• Participate in internal and supplier audits.
• Support external audits.
• Assist in CAPA management, change control, and non-conformity handling.
• Contribute to training activities related to QMS for employees.
• Prepare quality reports and provide transparency on quality performance.
• Collaborate with cross-functional teams to ensure quality standards are met.

Connaissances

Quality Assurance

Regulatory Affairs

Audits

CAPA

Change Control

Non-conformity Handling

Training

Quality Reports

Formation

Bachelor’s degree or higher in engineering, life sciences, or related field

Description du poste

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Would you like to contribute to improving the quality of life of people with hearing loss?

At Oticon Medical, we develop, produce and market bone-anchored hearing systems. At our site ITSA Medical in Vallauris (Sophia Antipolis), in the south of France, we specialize in the production of active implantable class III implants and soon also worldwide distribution of the company’s full product portfolio.

We are now seeking a QMS Specialist to support and maintain our Quality Management System (QMS) and ensure compliance with global regulatory requirements. Reporting to the QA Manager, you will play a key role in implementing, improving and merging local and global quality processes across the organization.

Responsibilities

• Support the maintenance and continuous improvement of the Global Quality Management System (QMS).
• Ensure compliance with applicable regulatory requirements (ISO 13485, MDSAP, MDR 2017/745).
• Review and update QMS procedures and documentation.
• Participate in internal and supplier audits.
• Support external audits.
• Assist in CAPA management, change control, and non-conformity handling.
• Contribute to training activities related to QMS for employees.
• Prepare quality reports and provide transparency on quality performance.
• Collaborate with cross-functional teams to ensure quality standards are met.

Profile

• Bachelor’s degree or higher in engineering, life sciences, or related field.
• Minimum 3–5 years of experience in Quality Assurance or Regulatory Affairs, preferably within medical devices or pharmaceutical industry.
• Good understanding of quality systems and regulatory standards.
• Structured, detail-oriented, and proactive approach.
• Strong communication, leadership, teamwork skills, and solution-oriented mindset.