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月薪范圍：登錄可見

招聘人數：1-2人

年齡要求：不限

所屬職能：其他

工作地點：無錫

學歷要求：不限

語言要求：不限

所屬崗位：其他

工作年限：不限

專業要求：不限

獎勵計劃

職位描述

POSITION SUMMARY（職位概述）

Take the responsibility of QA engineer for ensuring product quality realized with applying QMS requirements, product specification, production process control plan, quality analysis tools.

確保產品質量控制活動遵循了質量管理體系、產品規范、生產工藝、控制計劃的要求，并且應用恰當的質量分析工具。

KEY RESPONSIBILITIES（主要職責）

1. Production process management: check the quality control point for each key production steps, check the line clearance and cleaning results. Responsible for release of bulk product.

生產過程管理：對每批產品生產各環節的質量控制點進行檢查，對車間清場、清潔結果進行檢查。負責車間半成品的放行。

2. Reviewing for incoming test of raw material. Reviewing for batch production record, batch analytical record.

審核到貨檢驗結果。審核批生產記錄和批檢驗記錄。

3. Following the set-up quality procedures to handle quality issue with product processing from assembly, molding, filling and packing.

根據即定的質量程序處理來自裝配、注塑、灌裝和包裝過程的產品質量問題。

4. Involve in root cause and action addressing to QN/deviation/CAPA. Involve in evaluation and action addressing to change control management.

參入質量事件/偏差/ CAPA的根本原因調查和措施跟蹤，參入變更控制的評估流程和行動的跟蹤。

5. Review validation protocol and validation report. And responsible of sampling for validation sample and monitoring for execution of validation activities.

審核驗證方案和驗證報告。在驗證執行過程中負責取樣并監督驗證的執行。

6. Prepare relevant quality assurance procedure. Leading for preparing for control plan, p-FMEA, quality plan, etc

起草質量保證相關流程。領導建立控制計劃、P-FMEA、質量計劃等文件。

7. Responsible for sampling for product, retention sample and periodic inspection

負責車間取樣、留樣產品和周期檢驗。

8. Involve in supplier management, include supplier qualification evaluation, on-site audit, performance evaluation, compliant to supplier etc.

參入供應商管理，包括供應商初始確認評估、現場審計、供應商績效評估、供應商投訴等。

9. Support operation engineer for investigation to customer complaint and review investigation report for the result corrective, and accurate addressing customer complaint.

支持生產部工程師對客戶投訴進行調查，并審核調查報告及措施，精確解決客戶投訴。

10. Aware to national standard/regulation requirements of products for driving product compliance.

了解國家標準和法規要求并推動產品符合相應的要求。

11. EHS compliance in the responsible area

負責區域的EHS合規。

12. Other superior assigned work

上級指派其它的工作。

SKILLS AND ABILITIES（技能）

1. Bachelor degree with major for bio, pharma engineering relevant, or production mechanism/electronic/automation engineering relevant

本科或以上學歷畢業，生物工程，制藥工程相關專業，或機電工程自動化生產相關。

2. At least 3 years relevant work experience of QA engineers or supervisors in medical devices companies

至少3年以上醫療器械企業QA工程師或主管的相關工作經驗

3. Be familiar with relevant regulation requirements for medical devices, medical devices GMP requirements; medical device GMP/ISO 13485 requirements

熟悉國家有關的醫療器械的法規、熟悉醫療器械GMP要求、熟悉醫療器械GMP/ISO 13485要求。

4. team player with well communicative and cooperative,

具有良好溝通和協作能力的團隊成員

5. Fluent in listening and speaking in English and Chinese

中英文聽說讀寫流利；

企業簡介

Founded in 1897, BD is a world-wide leader of medical technology which manufactures and sells a broad range of supplies, devices and systems for use by healthcare professionals, medical research institutions, industry and the general public. We focus strategically on achieving growth in three worldwide business segments-BD Medical System (Core Medical, Consumer Healthcare, Pharmaceutical Systems, Ophthalmic Systems), BD Biosciences and BD Preanalytical Solutions. Our products are marketed in the United States and around the world. The latest Fortune magazine has listed BD in the top four “America’s Most Admired Companies” in the medical products, equipment category.
We believed in “Do what is right, Always seek to improve, Accept personal responsibility, Act in harmony.” Now we invite qualified, talented and self-motivated individual to develop with BD’s businesses in China.

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質量工程師(Flush)_宜興

職位描述

企業簡介

職位發布企業

蘇州碧迪醫療器械有限公司

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