Quality Engineer

Summary

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

, 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 Description

Lead the establishment and deployment of Product Quality systems in China, ensuring alignment with global QMS and

regulatory requirements.

•负责在中国建立并部署产品质量体系，确保与全球质量管理体系及法规要求保持一致

Drive transfer of Product Quality processes, standards, and best practices to ensure consistent and compliant execution.

推动产品质量流程、标准及最佳实践的转移，确保执行一致性与合规性

•Lead product quality management and continuous improvement through data analysis, root cause investigation, and

CAPA/NCMR/complaint handling.

•主导产品质量管理与持续改进，包括数据分析、根因调查及CAPA、NCMR、投诉处理。

Ensure QMS and regulatory compliance, including audit support and engineering change control (ECR/ECO).

确保质量体系及法规合规，包括审核支持及工程变更管理（ECR/ECO）

•Ensure China site compliance with ISO9001, ISO13485, and FDA 21 CFR Part 820 requirements, and support and lead

internal and external audits, including preparation, execution, and timely closure of audit findings.

确保中国工厂符合ISO9001、ISO13485及FDA 21 CFR Part 820法规要求，并支持和主导内外部审核，包括审核准备、执行及

问题的及时关闭

• Any agreed-to works by superiors.

上级安排其它的工作

The essential requirements of the job include

• Bachelor’s degree in Engineering or equivalent.

工程类本科或同等学历。

• 3-5 years experience in product or manufacturing quality.

3-5 年产品或制造质量经验。

• Experience in process transfer, NPI or site setup preferred.

具有流程转移、新产品导入或工厂建设经验者优先。

Excellent verbal and written communication skills, including ability to effectively communicate with internal and external

customers.

•具备优秀的口头和书面沟通能力，能够与内部及外部客户进行有效沟通。

• Organized and detail-oriented with a high level of initiative, self-motivation and energy

做事有条理、注重细节，并具备高度主动性、自我驱动力和充沛精力。

Travel, Motor Vehicle Record & Physical/Environment Requirements: 出差、机动车驾驶记录及身体/环境要求：

• Ability to travel –5% travel, overnight, within territory or occasional international travel

可接受出差——约5%的出差频率，需过夜，在所负责区域内出差或偶尔进行国际出差

It would be a plus if you also possess previous experience in: 如果您还具备以下经验将更具优势：

• Strong knowledge of ISO9001, ISO13485, FDA QSR, China NMPA

熟悉ISO9001、ISO13485, FDA 及 中国法规等。

• Familiar with quality tools such as FMEA, SPC, DOE, MSA.

熟悉FMEA、SPC、DOE、MSA等质量工具。

• Strong cross-site communication and stakeholder management skills.

具备良好的跨工厂沟通及协作能力。

• Willing to travel between Singapore and China.

可接受新加坡与中国之间的出差要求