【内部推荐】Senior Advanced QE 金属制造业 罗德岛# JobHunting - 待字闺中
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1 楼
手术器械制造OEM公司，在罗德岛这个点大约五六十个办公室员工（工程师）。我们质
量组有七个人，自从二月质量高工走后招人几经周折，到现在还没招到合适的人。如
果有兴趣请邮件我qirenyifan＠gmail.com。简历合适的话，我的老板大概会送上膝盖
抱着你痛哭一场。报酬视经验而定，据我猜测应该十万上下。
要求：
至少五年质控经验，最好是在医疗器械，汽车制造业或者航空制造业，熟悉ISO质量体
系，有CQE证书（或者类似证书，如six－sigma等）。适应美国家庭式企业氛围，幽默
友好，善于扯蛋或者被扯蛋。
More info:
What will you do as an Sr. Advanced Quality Engineer?
Act as the primary liaison for new program quality requirements with
customer.
Oversee AQE elements of New Product Development and ensure compliance to
business, quality system and regulatory requirements.
Provide direction in areas of validation/qualifications (IQ, OQ & PQ) and
design and implement methods and procedures for inspection, measurement and
test of received component product.
Lead efforts to obtain measurement device or instrumentation to perform
necessary product measurements. Perform measurement system analyses to
evaluate and qualify test and inspection equipment for new programs. Lead
efforts to improve measurement system results when needed.
Lead or co-Lead the development of quality documentation (FMEA, Control Plan
, Work Instructions etc.) required to achieve on time and successful program
commercialization.
Conduct internal quality audits.
Manage and support all aspects of program quality requirements prior to full
product commercialization: Customer complaints, internal non-conformance,
supply chain issues or non-conformances, measurement support etc.
What are we seeking in the ideal candidate?
The ideal candidate will have the following qualifications:
Bachelor’s Degree in Engineering or Quality related field desired.
At least 5 years quality engineer experience in a Medical Device or
component manufacturing facility or other highly regulated industry is
preferred.
Experience with FDA, ISO 9001:2008, and ISO 13485 is a strong plus.
Prior experiencing working in an advanced quality engineering capacity on
new products in a regulated industry preferred.
Must be adept in use of computer software for the analysis of data,
preferably Microsoft Excel and statistical packages such as Minitab.
Experience with regulatory requirements and ISO Certification inspections.
Knowledge in areas which include, but are not limited to: Statistics, SPC,
Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc.
Quality Engineering Certification (CQE) preferred or equivalent.
Ability to analyze, understand and effectively communicate technical data.
Strong customer communication skills.
Program management or new product launch team experience a strong plus.
Experience with ERP software or related databases preferred, experience with
scanning software, MS Office. Specific experience with Visual
Manufacturing ERP system considered a plus.
http://chc.tbe.taleo.net/chc01/ats/careers/requisition.jsp?org=CADENCE&cws=1&rid=587
量组有七个人，自从二月质量高工走后招人几经周折，到现在还没招到合适的人。如
果有兴趣请邮件我qirenyifan＠gmail.com。简历合适的话，我的老板大概会送上膝盖
抱着你痛哭一场。报酬视经验而定，据我猜测应该十万上下。
要求：
至少五年质控经验，最好是在医疗器械，汽车制造业或者航空制造业，熟悉ISO质量体
系，有CQE证书（或者类似证书，如six－sigma等）。适应美国家庭式企业氛围，幽默
友好，善于扯蛋或者被扯蛋。
More info:
What will you do as an Sr. Advanced Quality Engineer?
Act as the primary liaison for new program quality requirements with
customer.
Oversee AQE elements of New Product Development and ensure compliance to
business, quality system and regulatory requirements.
Provide direction in areas of validation/qualifications (IQ, OQ & PQ) and
design and implement methods and procedures for inspection, measurement and
test of received component product.
Lead efforts to obtain measurement device or instrumentation to perform
necessary product measurements. Perform measurement system analyses to
evaluate and qualify test and inspection equipment for new programs. Lead
efforts to improve measurement system results when needed.
Lead or co-Lead the development of quality documentation (FMEA, Control Plan
, Work Instructions etc.) required to achieve on time and successful program
commercialization.
Conduct internal quality audits.
Manage and support all aspects of program quality requirements prior to full
product commercialization: Customer complaints, internal non-conformance,
supply chain issues or non-conformances, measurement support etc.
What are we seeking in the ideal candidate?
The ideal candidate will have the following qualifications:
Bachelor’s Degree in Engineering or Quality related field desired.
At least 5 years quality engineer experience in a Medical Device or
component manufacturing facility or other highly regulated industry is
preferred.
Experience with FDA, ISO 9001:2008, and ISO 13485 is a strong plus.
Prior experiencing working in an advanced quality engineering capacity on
new products in a regulated industry preferred.
Must be adept in use of computer software for the analysis of data,
preferably Microsoft Excel and statistical packages such as Minitab.
Experience with regulatory requirements and ISO Certification inspections.
Knowledge in areas which include, but are not limited to: Statistics, SPC,
Geometric Dimensioning/Tolerancing; Sampling, Design of Experiments, etc.
Quality Engineering Certification (CQE) preferred or equivalent.
Ability to analyze, understand and effectively communicate technical data.
Strong customer communication skills.
Program management or new product launch team experience a strong plus.
Experience with ERP software or related databases preferred, experience with
scanning software, MS Office. Specific experience with Visual
Manufacturing ERP system considered a plus.
http://chc.tbe.taleo.net/chc01/ats/careers/requisition.jsp?org=CADENCE&cws=1&rid=587