基本信息
工作性质全职
招聘人数1人
招聘部门不限
学历要求本科
工作经验1-3年
年龄要求不限
工作地点宜兴市新街街道绿园路888-8号（江苏/无锡/宜兴市）
联系方式
联系人：Vanessa ( 联系我时，请说是在宜兴人才网上看到的 )
联系电话：0510-0512-6****803
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职位动态
100%
近两周该职位的简历处理率
简历处理率0天
简历平均处理时长
2019-08-08
企业最近登录时间
职位描述
POSITION SUMMARY（职位概述）
Take the responsibility of QA engineer for ensuring product quality realized with applying QMS requirements, product specification, production process control plan, quality analysis tools.
确保产品质量控制活动遵循了质量管理体系、产品规范、生产工艺、控制计划的要求，并且应用恰当的质量分析工具。
KEY RESPONSIBILITIES（主要职责）
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.
生产过程管理：对每批产品生产各环节的质量控制点进行检查， 对车间清场、清洁结果进行检查。负责车间半成品的放行。
2. Reviewing for incoming test of raw material. Reviewing for batch production record, batch analytical record.
审核到货检验结果。审核批生产记录和批检验记录。
3. Following the set-up quality procedures to handle quality issue with product processing from assembly, molding, filling and packing.
根据即定的质量程序处理来自装配、注塑、灌装和包装过程的产品质量问题。
4. Involve in root cause and action addressing to QN/deviation/CAPA. Involve in evaluation and action addressing to change control management.
参入质量事件/偏差/ CAPA的根本原因调查和措施跟踪，参入变更控制的评估流程和行动的跟踪。
5. Review validation protocol and validation report. And responsible of sampling for validation sample and monitoring for execution of validation activities.
审核验证方案和验证报告。在验证执行过程中负责取样并监督验证的执行。
6. Prepare relevant quality assurance procedure. Leading for preparing for control plan, p-FMEA, quality plan, etc
起草质量保证相关流程。领导建立控制计划、P-FMEA、质量计划等文件。
7. Responsible for sampling for product, retention sample and periodic inspection
负责车间取样、留样产品和周期检验。
8. Involve in supplier management, include supplier qualification evaluation, on-site audit, performance evaluation, compliant to supplier etc.
参入供应商管理，包括供应商初始确认评估、现场审计、供应商绩效评估、供应商投诉等。
9. Support operation engineer for investigation to customer complaint and review investigation report for the result corrective, and accurate addressing customer complaint.
支持生产部工程师对客户投诉进行调查，并审核调查报告及措施，精确解决客户投诉。
10. Aware to national standard/regulation requirements of products for driving product compliance.
了解国家标准和法规要求并推动产品符合相应的要求。
11. EHS compliance in the responsible area
负责区域的EHS合规。
12. Other superior assigned work
上级指派其它的工作。
SKILLS AND ABILITIES（技能） 1. Bachelor degree with major for bio, pharma engineering relevant, or production mechanism/electronic/automation engineering relevant
本科或以上学历毕业，生物工程，制药工程相关专业， 或机电工程自动化生产相关。
2. At least 3 years relevant work experience of QA engineers or supervisors in medical devices companies
至少3年以上医疗器械企业QA工程师或主管的相关工作经验
3. Be familiar with relevant regulation requirements for medical devices, medical devices GMP requirements; medical device GMP/ISO 13485 requirements
熟悉国家有关的医疗器械的法规、熟悉医疗器械GMP要求、熟悉医疗器械GMP/ISO 13485要求。
4. team player with well communicative and cooperative,
具有良好沟通和协作能力的团队成员
5. Fluent in listening and speaking in English and Chinese
中英文听说读写流利；
Take the responsibility of QA engineer for ensuring product quality realized with applying QMS requirements, product specification, production process control plan, quality analysis tools.
确保产品质量控制活动遵循了质量管理体系、产品规范、生产工艺、控制计划的要求，并且应用恰当的质量分析工具。
KEY RESPONSIBILITIES（主要职责）
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.
生产过程管理：对每批产品生产各环节的质量控制点进行检查， 对车间清场、清洁结果进行检查。负责车间半成品的放行。
2. Reviewing for incoming test of raw material. Reviewing for batch production record, batch analytical record.
审核到货检验结果。审核批生产记录和批检验记录。
3. Following the set-up quality procedures to handle quality issue with product processing from assembly, molding, filling and packing.
根据即定的质量程序处理来自装配、注塑、灌装和包装过程的产品质量问题。
4. Involve in root cause and action addressing to QN/deviation/CAPA. Involve in evaluation and action addressing to change control management.
参入质量事件/偏差/ CAPA的根本原因调查和措施跟踪，参入变更控制的评估流程和行动的跟踪。
5. Review validation protocol and validation report. And responsible of sampling for validation sample and monitoring for execution of validation activities.
审核验证方案和验证报告。在验证执行过程中负责取样并监督验证的执行。
6. Prepare relevant quality assurance procedure. Leading for preparing for control plan, p-FMEA, quality plan, etc
起草质量保证相关流程。领导建立控制计划、P-FMEA、质量计划等文件。
7. Responsible for sampling for product, retention sample and periodic inspection
负责车间取样、留样产品和周期检验。
8. Involve in supplier management, include supplier qualification evaluation, on-site audit, performance evaluation, compliant to supplier etc.
参入供应商管理，包括供应商初始确认评估、现场审计、供应商绩效评估、供应商投诉等。
9. Support operation engineer for investigation to customer complaint and review investigation report for the result corrective, and accurate addressing customer complaint.
支持生产部工程师对客户投诉进行调查，并审核调查报告及措施，精确解决客户投诉。
10. Aware to national standard/regulation requirements of products for driving product compliance.
了解国家标准和法规要求并推动产品符合相应的要求。
11. EHS compliance in the responsible area
负责区域的EHS合规。
12. Other superior assigned work
上级指派其它的工作。
SKILLS AND ABILITIES（技能） 1. Bachelor degree with major for bio, pharma engineering relevant, or production mechanism/electronic/automation engineering relevant
本科或以上学历毕业，生物工程，制药工程相关专业， 或机电工程自动化生产相关。
2. At least 3 years relevant work experience of QA engineers or supervisors in medical devices companies
至少3年以上医疗器械企业QA工程师或主管的相关工作经验
3. Be familiar with relevant regulation requirements for medical devices, medical devices GMP requirements; medical device GMP/ISO 13485 requirements
熟悉国家有关的医疗器械的法规、熟悉医疗器械GMP要求、熟悉医疗器械GMP/ISO 13485要求。
4. team player with well communicative and cooperative,
具有良好沟通和协作能力的团队成员
5. Fluent in listening and speaking in English and Chinese
中英文听说读写流利；
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