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QA Engineer
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Key Responsibilities:
1. Lead / participate in project related quality activities (e.g. design control, change control, product release) and provide quality consultation to the team.
2. Demonstrate customer focus, cross-functional cooperation skills, and sound quality judgement.
3. Complete the evaluation and detailed investigation on the observed nonconformities during manufacturing process.
4. Present accumulated quality data to customers and management.
5. Identify trends of quality data with the usage of statistics and quality improvement tools to prevent quality issues.
6. Ability to effectively communicate and interact with foreign customer, team members, and various technical disciplines.
7. Support external quality inspections and execute internal and supplier audits.
8. Complete assigned tasks on time with minimal supervision (self-motivated).
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1. BS degree above or equivalent technical work experience.
2. Clear / logical thinking with strong organization and communication skills
3. Proficient problem solving skills.
4. Working knowledge of Microsoft Office.
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現有職缺5名
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桃園市蘆竹區
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42,000 以上
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Audit Specialist
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Key Responsibility:
1. Gather regulatory data from NBs and regulatory agencies, and perform assessments on regulatory issues.
2. Compile, review and submit regulatory applications, and in support of customer product registration.
3. Responsible for facilities registration with regulatory agencies.
4. Applicable regulatory Implement/improvement.
5. Collaborate with other departments to ensure quality and regulatory activities are performed in accordance with Quality policy.
6. Collaborate with SHL Global RA Team to develop and implement strategies for the regulatory submission and improvement
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1. BS degree above or equivalent technical work experience.
2. Clear / logical thinking with strong organization and communication skills
3. Proficient problem solving skills.
4. Working knowledge of Microsoft Office.
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現有職缺1名
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桃園市蘆竹區
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42,000 以上
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Quality Engineer (Supplier Management)
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Key Responsibility:
1. Author procedures, work instructions or other documents.
2. Review completeness of the Device History Records.
3. Issue Corrective and Preventive Actions (CAPA), leads cross functional team to perform root cause analysis and identify corrective actions.
4. Verify the effectiveness of corrective/preventive actions.
5. Assist QA Manager by participating in Non-Conforming Product, complaint, CAPA investigation.
6. Provide training to other function members in QA systems.
7. Participate in internal audits, and when require external audits.
8. Interfaces with other functions' members, customers and/ or suppliers to resolve issues.
9. Lead and draft Supplier Quality Agreement.
10. Evaluate and audit supplier (routine and ad hoc).
11. Review and approves supplier failure analysis relative to corrective action provided, and coordinate resolution of quality assurance related problems.
12. Identify, investigate, analyze and correct problems in quality, production and control at supplier locations, and escalate to QA Manager if any major systemic/production failures observed.
13. Drive supplier quality performance improvements.
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1. BS degree above or equivalent technical work experience.
2. Clear / logical thinking with strong organization and communication skills
3. Proficient problem solving skills.
4. Working knowledge of Microsoft Office.
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現有職缺1名
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桃園市蘆竹區
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42,000 以上
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Regulatory Affairs Specialist
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Key Responsibility:
1. Gather regulatory data from NBs and regulatory agencies, and perform assessments on regulatory issues.
2. Compile, review and submit regulatory applications, and in support of customer product registration.
3. Responsible for facilities registration with regulatory agencies.
4. Applicable regulatory Implement/improvement.
5. Collaborate with other departments to ensure quality and regulatory activities are performed in accordance with Quality policy.
6. Collaborate with SHL Global RA Team to develop and implement strategies for the regulatory submission and improvement
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1. BS degree above or equivalent technical work experience.
2. Clear / logical thinking with strong organization and communication skills
3. Proficient problem solving skills.
4. Working knowledge of Microsoft Office.
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現有職缺1名
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桃園市蘆竹區
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42,000 以上
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Process Engineer
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Key Responsibility:
1. Analyze manufacturing operation OEE, production, yield, cost and capability and provide improvement plan.
Write or modify WI and SOP.
2. Control and adjust machine parameters and problem solving.
3. Establish the projects of Machine OEE, production operation and capability improvement.
4. Collaborate with other department to develop and implement strategies.
5. Provide training for operator, foreman and technician.
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1. 英文文件讀寫能力。
2. 個性樂觀、主動積極、團隊合作、高抗壓性。
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現有職缺2名
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桃園市蘆竹區
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42,000 以上
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Project Engineer
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Key Responsibilities:
1. Plan the flow chart of manual assembly, semi-auto assembly, and fully auto assembly process.
2. Check the EURS of assembly fixtures and equipment at engineering phase.
3. Confirm the functionality of fixtures and equipment to meet the EURS.
4. Establish the standard working instruction.
5. Develop and improve the assembly process to increase the capacity
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1.熟悉組裝製程，且具備製程規劃能力
2.具備讀寫Solidworks
3.熟悉Office文書軟體
4.具備基礎英文溝通能力(多益700分以上)
5.良好的團隊合作與溝通技巧
6.期望特質：獨立、積極、細心
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現有職缺4名
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桃園市蘆竹區
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42,000 以上
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