Quality System Development Manager

Job summary

The Quality System Development Manager will oversee and enhance the Corporate Quality System within a medical device company, ensuring compliance and high-quality standards across operations. This role involves collaboration with various stakeholders and continuous improvement initiatives.

Qualifications

• Extensive experience with Quality Systems in medical device or pharmaceutical industries (ISO 13485:2016, MDSAP, MDR/IVD, FDA QMSR).
• Certification as an ISO 13485 auditor.
• Training in MDSAP/MDR.
• Strong skills in cross-functional collaboration and stakeholder management.
• Proficient in problem-solving tools.
• Fluent in English, both spoken and written.

Responsibilities

• Manage and develop the corporate quality system with support from process owners.
• Plan and conduct internal audits of the Quality Management System (QMS).
• Organize and follow up on audits from notified bodies, customers, and authorities.
• Conduct corporate audits at various GN Hearing sites and contract manufacturers in Europe.
• Maintain notified body basic data and certificates.
• Communicate significant changes to notified bodies.
• Evaluate local suppliers and maintain their certificates within the QMS.
• Act as a Subject Matter Expert (SME) for defined processes.
• Oversee all relevant QMS activities.
• Maintain E-Learning on Quality & Regulatory requirements.

Education

• Relevant degree in a related field is preferred but not explicitly stated.

Tools

• Familiarity with quality management software and auditing tools is implied but not specified.