• Provide quality assurance services to ensure the integrity of products received and shipped out, services provided to clients, support business and customer needs, and comply with government regulations.
• Responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development.
• Manage process and product non-conformances in line with company procedures.
• Conduct quality assurance tests to ensure product specifications are met, and review, investigate, resolve and report on quality discrepancies.
• Develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.
• Accompany audit and inspection preparation, resolution of audit and inspection findings.
• Coordinate audits (internal and external): plan audits and ensure smooth audit completion as well as manage Audit Documentation.
• Masters (Life Sciences) with several years of experience in Quality Management
• Knowledge of regulatory requirements for Medical Device Quality Management – ISO 13485, ISO 14971, 21 CFR Part 820, IVDD / IVDR
• Experience in Non-conformance / Deviation / CAPA Management
• Experience in implementation of GDP, 21 CFR Part 11
The following are an added advantage:
• Certified Internal / Lead auditor for Medical Device Quality Management OR
Implementation course for ISO 13485
• Language skills – Fluent spoken and written English. German is an advantage.
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