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 managing Quality Systems in medical device or pharmaceutical industries.
• Certification as an ISO 13485 auditor.
• Training in MDSAP and 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 approximately 1000 users.
• 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 across multiple global sites and contract manufacturers.
• Maintain notified body data and certificates.
• Communicate significant changes to notified bodies.
• Coordinate evaluations of local suppliers within the QMS.
• Serve as a Subject Matter Expert (SME) for defined processes.
• Monitor all relevant QMS activities.
• Maintain e-learning modules on Quality and Regulatory requirements.

Education

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

Tools

• Familiarity with ISO 13485:2016, MDSAP, MDR/IVD, and FDA QMSR standards.