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:

Knowledge of quality system standards and regulations: FDA QSR, ISO 9000 and ISO 13485 standards, MDD, etc.了解质量体系标准和法规： FDA QSR、ISO 9000、ISO 13485标准、MDD等。Qualified to conduct ISO 13485, ISO 9000 and GMP audits.具有进行ISO 13485、ISO 9000和GMP审核的资格。Have a good record of employment in medical device organizations.具有良好的医疗器械单位任职记录。Excellent interpersonal and communication skills; ability to work in cross-functional teams.具有良好的人际交往和沟通能力；有能力在跨职能团队中工作。Ability to think clearly, analyze processes and provide solutions.思维清晰，具有流程分析能力，有能力提供解决方案。Ability to handle simultaneous tasks and prioritize accordingly.具有同时处理多项事务的能力以及确定相应优先级的能力。Demonstrates excellent written, oral and interpersonal skills with personnel at all levels.具有与各级人员进行良好的书面、口头和人际交往的能力。Exhibits a high degree of integrity, initiative and motivation.具有高度的诚信、主动性和积极性。A BS in science or other technical discipline is required with 5-7 years directly relevant experience in a medical device or pharmaceutical quality assurance setting, or equivalent industry experience.具有理学或其他技术专业学士学位，具有5-7年的医疗器械或药品质量保证机构直接相关经验，或同等行业经验。Trained Quality System Auditor for GMP or ISO audits.经过GMP或ISO审核培训的质量体系审核员。

Operating Company:

DEXIS

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