Quality Systems Specialist - #263294

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We develop, manufacture, and supply dental implants, clear aligners, instruments, CADCAM prosthetics and biomaterials for use in esthetic dentistry, tooth replacement and restoration solutions or to prevent tooth loss.

We empower our employees to perform and make an impact, to question the status quo, to drive change, to stay ahead of the competition. From the first Dental Implant in 1974 to the latest Digital Solution – we do things differently than others

We deliver innovation based on evidence. This is part of our employer culture as well as an exceptional team spirit that truly encourages diversity and a powerful “can-do” attitude.

#WeChangeDentistry every day. Be part of it.

Position Summary

The Quality Assurance (QA) Specialist is the process owner of quality processes and systems, ensuring compliance with applicable Quality System Regulations and ISO Standards. Monitoring Quality QMS system and processes, including audit program, document control, training, CAPA, record retention, nonconformity, and customer complaint investigation. The candidate collaborates with cross-functional teams to monitor operational processes to ensure compliance with applicable Quality System Regulations and ISO Standards. Job Responsibilities:

This position is responsible for, but not limited to, the following:

• Maintain the company's eQMS modules including Document Control Management, Training Management, Change Management, Nonconformity and CAPA Management.
• Maintain Quality Management System (QMS) processes and procedures, and records required to manage product and regulatory requirements.
• Lead the company training program, nonconformity (NCR); SCAR (Supplier Corrective Action Request) programs.
• Reviews quality trends based on collected quantitative data and interactions with quality inspectors and operations personnel.
• Acquires skills and experience necessary to perform Quality Assurance tasks without supervision.
• Collaborates with the process owners and Subject Matter Experts to generate new documents or update documents to comply with industry regulations and corporate requirements.
• Assist quality improvement projects by participating and supporting project teams, resources, stakeholder relationships, timelines, and milestones.
• Execute incoming inspection and raw materials release.
• Manages and maintains supplier performance in coordination with a multidisciplinary team.
• Monitor and support the multidisciplinary team to implement the CAPA program.
• Conduct customer complaint investigations, implement correction or corrective action as required.
• Coordinate and prepare site audit from health authority, notified body and key customers.
• Accurately records and reports information as required.
• Support change control, technical transfer, or new product introduction in coordination with the multidisciplinary team.
• Assists in maintaining the company's Risk Management programs.
• Assist in product and process validation as required.
  
  

Non-essential Functions And Duties

• Attends Quality and other meetings as required.
• Participates in additional training relevant to this position.
• Other duties may be assigned, directed or requested.
  
  

Physical Attributes

The requirements described here ar

主要工作职能：

Major Accountabilities

• 参与制定和实施具体的设计方案 Participate in the formulation and implementation of specific design plans.
• 积极参与设计方案的讨论和评审，并提供建设性意见 Actively engage in discussions and reviews of design plans, providing constructive feedback.
• 主动承担项目中比较困难和有挑战的开发任务 Take initiative to undertake challenging and complex development tasks in projects.
• 协助技术专家制定技术规范和开发流程 Assist technical experts in establishing technical standards and development processes.
• 积极指导和帮助团队中较为初级的成员完成开发任务 Actively guide and support junior team members in completing development tasks.
  
  

任职要求：

Requirements

• 计算机科学、软件工程或相关计算机领域的本科及以上学历，6年以上软件开发的工作经验 Participate in the formulation and implementation of specific design plans. At least 6 years of experience in software development.
• 熟悉软件开发的流程、方法和工具； Familiar with software development processes, methods, and tools.
• 精通C++和标准库及Boost常用程序库； Proficient in C++ and commonly used libraries such as the Standard Library and Boost.
• 有强烈的代码规范意识，熟悉Google代码规范； Strong awareness of code standards, well-versed in Google coding standards.
• 熟悉多线程技术和各种线程同步方法，能熟练使用标准库中的线程； Experienced in multithreading techniques and various thread synchronization methods, with expertise in using threads in the Standard Library.
• 熟悉CMake和跨平台编程要点； Familiar with CMake and key aspects of cross-platform development.
• 专业的分析和解决问题的能力，能独自面对挑战性问题； Professional analytical and problem-solving skills, capable of independently tackling challenging issues.
• 对技术能持续学习和精进，对自己的技术路线有完整的规划； Commitment to continuous learning and improvement in technology, with a clear and comprehensive personal technical roadmap.
  
  

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