Quality Engineer (Microbiology)

Job Description:

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, industry and OpCo standards. May be responsible for supplier selection & auditing, material qualification, material inspection and test, performance monitoring and supplier development. May manage process and product non-conformances in line with company procedures. May conduct quality assurance tests to ensure product specifications are met. May review, investigate, resolve and report on quality discrepancies. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards. May monitor, investigate, and report on customer complaints. May obtain the necessary quality system certifications and licenses (e.g. ISO, CE) to support market release of new product development. May lead audit and inspection preparation, resolution of audit and inspection findings. May have frequent interaction with other functional areas and operating entities.

Job Requirements:

• College or above with Good English skill both in written and oral.
• 3 years or more of relevant working experience in microbiological quality control or inspection in the medical device company (experience in sterile implants, interventional or Class III medical devices is preferred).
• Proficient in quality management system regulations such as GMP,ISO 13485 (GB/T 42062) and Chinese Pharmacopoeia and well-versed in sterilization standards like ISO11137.
• Skill in the standard operations and principles of sterility testing, endotoxin testing, and environmental monitoring.
• Have a solid theoretical foundation in microbiology and rich practical experience, and be familiar with common aseptic testing methods.
• Possess strong capabilities in deviation investigation and root cause analysis, and be proficient in using CAPA tools.
• Excellent skills in literature retrieval, data statistical analysis and report writing.
• Skilled in using Office software and various quality management software.
• Good communication and teamwork skill.
• With responsible, and careful personality.

Operating Company:

Nobel Biocare

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