Salary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
新北市中和區
Required
Language Requirements
English
聽/中等、說/中等、讀/中等、寫/中等
Work Experience
2年以上
Job Description
About the Job
As a Quality Assurance Specialist, you will play a crucial role in ensuring our products meet the highest standards of quality and reliability. Your expertise will help us maintain our commitment to excellence as we continue to grow and innovate.
作為品保專員，您將在確保我們產品達到最高品質標準方面發揮關鍵作用。您的專業知識將幫助我們維持對卓越的承諾，隨著我們的成長與創新，您將成為重要的一環。
Why We Have This Role
This position is essential for maintaining the integrity of our processes and products. By identifying and mitigating risks, you will help us uphold our reputation for quality and contribute to our overall success. Your work will directly impact customer satisfaction and the long-term sustainability of our operations.
此職位對於維護我們流程與產品的完整性至關重要。透過識別和降低風險，您將幫助我們保持質量聲譽，並對我們的整體成功做出貢獻。您的工作將直接影響客戶滿意度和我們業務的長期可持續性。
How You'll Find Success
To thrive in this role, you will need a keen eye for detail, a proactive approach to problem-solving, and strong communication skills. You will succeed by:
1.Conducting thorough quality inspections and audits.
2.Collaborating with cross-functional teams to implement best practices.
3.Analyzing data to identify trends and recommend improvements.
4.Ensuring compliance with industry standards and regulations.
要在此職位中茁壯成長，您需要具備敏銳的細節觀察能力、主動的問題解決能力以及良好的溝通技巧。您將通過以下方式取得成功：
1.進行徹底的品質檢查和審核。
2.與跨部門團隊合作，實施最佳實踐。
3.分析數據以識別趨勢並提出改進建議。
4.確保遵守行業標準和法規。
How You'll Grow
In this dynamic environment, you will have ample opportunities for professional development. You will be encouraged to:
1.Pursue relevant certifications and training.
2.Take on challenging projects that expand your skill set.
3.Collaborate with experienced professionals who will mentor you along the way.
在這個充滿活力的環境中，您將擁有豐富的專業發展機會。我們鼓勵您：
1.追求相關的認證和培訓。
2.接受挑戰性的專案，以擴展您的技能。
3.與經驗豐富的專業人士合作，獲得指導。
Things You Will Do
As a Quality Assurance Specialist, you will assist the Lead Auditor in executing specific quality management tasks, which include:
1.Maintenance and Improvement of the Quality Management System (QMS)
You will be responsible for developing, implementing, and maintaining the company’s internal Quality Management System (QMS) to ensure compliance with medical device regulations, such as ISO 13485 and GMP. This includes regularly reviewing and improving quality processes to ensure ongoing regulatory compliance.
2.Document Control and Record Management
You will manage all quality-related documents and records, ensuring they are updated, accurate, and compliant with regulations. This includes standard operating procedures (SOPs), design and manufacturing records, validation and verification documents, and more.
3.Internal and External Audits
In addition to assisting in planning and executing internal audits to ensure compliance with the quality management system across departments, you will also prepare for and support external audits, such as those conducted by government or third-party organizations.
4.Risk Management and CAPA System
You will participate in risk assessment and management, as well as take responsibility for the Corrective and Preventive Action (CAPA) system. This involves identifying and addressing non-conformances, analyzing root causes, and implementing effective preventive measures.
5.Ensuring Regulatory Compliance
You will collaborate with the regulatory affairs department to ensure that all products and processes comply with applicable regulatory requirements, including those set by TFDA and other relevant authorities.
協助主要稽核員執行具體的質量管理工作，詳細如下：
1. 品質管理系統的維護與改善： 負責制定、實施和維護公司內部的品質管理系統（QMS），確保符合醫療器械法規標準，如ISO 13485或GMP。這包括定期審查和改進質量流程，確保持續符合法規要求。
2. 文件控制與記錄管理： 負責管理與質量相關的所有文件和記錄，確保其更新、正確且遵循規定，包括標準操作程序（SOP）、設計和製造記錄、驗證和確認文檔等。
3. 內外部審核：除協助計劃並執行內部審核以確保公司各部門遵守品質管理系統的要求外，還需要準備並支持外部審核(如政府或第三方機構的審查)。
4. 風險管理與CAPA系統：參與風險評估與管理，並負責糾正和預防措施（CAPA）系統，識別和處理不符合項，分析根本原因並制定有效的預防措施。
5. 確保法規合規性： 與法規事務部門合作，確保所有產品和流程符合法規要求，包括TFDA等。
Number of Openings
1~1人
Educational Requirements
專科以上
Work Schedule
日班
Leave Policy
依公司規定
Job Skills
ISO document release management
Planning and Implementation of Quality Management System
Standard Operating Procedure Planning
ISO文件發行管理 標準作業流程規劃 規劃並執行品質管理系統
Job Category
Quality Control / Inspection Staff
QA / QC Engineer
ISO / Quality Assurance Staff
新北市中和區
其他醫療保健服務業
科林創立於1986年，現已發展為集團的規模，涵蓋B2B和B2C的營運模式，我們致力於鑽研與創新，提供跨越眼科、聽力、睡眠及營養保健等多元領域的綜合性醫療解決方案。我們不斷拓展科技知識與技術的邊界，旨在超越當前醫療保健的局限，創造顯著且永續的價值。深入理解病患的真正需求並提供有效的解決方案進而塑造卓越的健康和生活品質。我們的願景為成為亞太地區引領科技研發的醫療照護公司，通過不斷創新、整合和擴展服務範圍，為更多人和地區提供先進且值得信賴的健康照護。
我們的價值觀：
• 誠信與尊重
• 創新與持續優化
• 品質承諾與客戶導向
• 合作與人才發展
• 社會責任與永續發展
如果你/妳是富有使命感的人
如果你/妳認同社會道德責任
如果你/妳有滿腔的熱血想一展長才
歡迎加入我們!
一起創造一個不一樣的醫療保健市場
--
我們的歷史
→亞洲第一家通過ISO 9001認證的醫療儀器代理商
→1999年獲得衛生署生物醫學技術獎----醫療儀器類
→第一家醫療代理商通過ISO 13485醫療器材品質管理系統
→第一家助聽器門市服務通過SGS Qualicert服務驗證
→榮獲:2013年幸福心職場最高榮譽[金心獎]
→榮獲:2014年TTQS銀牌認證
→榮獲:衛生福利部國民健康署頒發:健康職場認證
→榮獲:新北市2020年度促進身心障礙者就業績優單位
→榮獲:公益微電影「老爸幫幫忙」榮獲2020年台灣YouTube最成功廣告影片排行榜
→榮獲:2022年新北企業精典獎「多元服務」獎項肯定
→榮獲:2023年獲業界第一家通過「醫療器材優良運銷準則(GDP)」認證
→榮獲:2024年科林助聽器榮獲經濟部第七屆潛力中堅企業獎
Clinico was founded in 1986 and has now developed into a group that encompasses both B2B and B2C operational models. We are dedicated to research and innovation, providing comprehensive medical solutions across various fields, including ophthalmology, otology, polysomnography and nutritional health. We continuously push the boundaries of technological knowledge and expertise, aiming to transcend the limitations of current healthcare and create significant and sustainable value. By deeply understanding the true needs of patients and offering effective solutions, we strive to shape excellent health and quality of life. Our vision is to become a leading healthcare company in the Asia-Pacific region, pioneering technological research and development. Through continuous innovation, integration, and service expansion, we aim to provide advanced and trustworthy healthcare to more people and regions.
Our values:
• Integrity and Respect
• Innovation and Continuous Improvement
• Quality Commitment and Customer Orientation
• Collaboration and Talent Development
• Social Responsibility and Sustainable Development
Our History
→The first medical instrument agency in Asia to obtain ISO 9001 certification.
→Awarded the Biomedical Technology Award by the Department of Health in 1999 for Medical Instruments.
→The first medical agency to pass the ISO 13485 Medical Device Quality Management System.
→The first hearing aid service center to receive SGS Qualicert Service Certification.
→Honored with the "Gold Heart Award" for Workplace Happiness in 2013.
→Awarded the TTQS Silver Certification in 2014.
→Recognized by the Ministry of Health and Welfare for the Workplace Health Certification.
→Recognized as an outstanding unit for promoting the employment of disabled individuals by New Taipei City in 2020.
→Won the award for the public service microfilm "Dad, Help!" which ranked among Taiwan's most successful YouTube ads in 2020.
→Awarded the "Diverse Services" recognition at the 2022 New Taipei City Business Excellence Awards.
→Became the first in the industry to be certified under the Good Distribution Practice (GDP) for medical devices in 2023.
→In 2024, Clinico Hearing Aids received the Ministry of Economic Affairs' Potential Mid-Sized Enterprise Award.
