Latvia MGI tech (MGI, www.en/mgitech.com) is committed to enabling effective and affordable healthcare solutions for all. Based on its proprietary technology, MGI produces sequencing devices, equipment, consumables, and reagents to support life science research, medicine, and healthcare. MGI's multi-omics platforms include genetic sequencing, mass spectrometry, and medical imaging. Providing real-time, comprehensive, life-long solutions, its mission is to develop and promote advanced life science tools for future healthcare

Latvia MGI Tech, a part of BGI Group - one of the world’s leading genomics organizations, is looking for a full-time Quality Manager.

Role: Implement, manage and work with the quality management system, based on good practice, legislation, and company needs.

Responsibilities:
• Establish and maintain the company’s quality management system and ensure it complies with related medical laws & regulations (IVDR, ISO13485, MDSAP, etc.)
• Provide leadership and guidance on people to implement and improve the quality processes across departments, according to the ISO13485 standards and internal procedures.
• Manage calibration, complaint handling, document control, and quality training.
• Maintain all quality records, logs, and other documents according to the ISO13485 standards and internal procedures.
• Ownership of the Corrective/Preventive Action (CAPA) system and direct investigations to resolve complaints and non-compliance instances. Implement corrective action plans to correct non-compliance issues.
• Provide guidance and participate where appropriate in Feasibility, Development, Design Verification, Design Validation, Design Transfer, and Commercialization reviews and activities from a quality and documentation perspective.
• Manage internal/external audits, management review meetings, and quality objectives.

Qualification:
• Bachelor’s degree in the related field.
• Extensive working knowledge of IVDR and ISO 13485.
• A thorough understanding of Quality Management System, including documentation control, process approach, CAPA, internal audit, management review, etc.
• High attention to details.
• Familiarity with manufacturing processes related to medical devices/agents.
• Strong problem-solving skills.
• 5+years of experience in medical-related companies.
• Strong interpersonal communication skills and teamwork skills.
• Fluent in verbal and written communication skills in Latvian, English (and Chinese).