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Manage
工作综述
Job
Function:
?
管理质量保证、质量工程和质量控制团队,使其符合
CFDA
、国际和总部法规的要求和标准,牵头生
产过程中的质量保证和过程统计控
制,并参所有形式的项目。
The
overall
responsibility
of
this
position
is
to
manage
quality
assurance,
q
uality
engineering
and
quality
control
teams
pursuant
to
CFDA,
international
a
nd
corporate
regulatory
requirements
and
standards;
lead
quality
assurance
and
statistical
process
control
in
manufacturing
with
hands-on
approach
as
a
tea
m
member
throughout
all
phases
of
projects.
C.
工作职责
Job
Description
?
p>
向该职位直接汇报的相关主管包括
QA/QE
主管
,
SQE
主管
;
Direct
reports
would
be
the
supervisors
within
the
quality
assurance
departmen
t
including
but
not
limited
toQA/QE
supervisor.
?
p>
建立这些主管们的工作目标,并确保直接汇报给这些主管们的下属的工作目标可以很好的被维
护、
跟踪和监控
;
Setting
up
of
their
G&O
and
ensure
each
of
their
direct
reports
JD
are
wel
l
maintained
and
followed
up
and
monitored.
?
和发送方、设计团队、供应商(如果涉及到)等一起牵头或指导客户投诉处理流程,更关
键的是确
保根本原因和纠正措施被有效实施
;
Lead
and/or
guide
the
customer
complaint
handling
process
by
working
with
sen
ding
sites,
design
team,
suppliers
(if
applicable)
to
contain
the
issues,
and
more
importantly
find
root
causes
and
corrective
actions
to
be
taken
?
< br>和相关职能部门一起通过利用质量工具和
6-Sigma
精益方法牵头和引导产品质量改善动作
(SPC,
MSA,
PFMEA,
Control
Plan,
Kaizen
Event,
etc);
Lead
and
drive
product
quality
improvement
initiatives
with
cross
functional
t
eams
by
utilizing
quality
tools
and
Lean
6-Sigma
methodologies
(SPC,
MSA,
PFM
EA,
Control
Plan,
Kaizen
Event,
etc).
?
< br>在定义、执行或跟踪系统纠正预防措施的时执行或提供相关指导或支持,并根据过程质量和质量问
题情况批准纠正预防措施
;
Performs
and
provides
guidance
and/or
assist
in
defining,
implementing
and
fol
low-up
of
systematic
corrective
and
preventive
actions
(CAPA)
and
approves
CAP
As
associated
to
quality
process
and
quality
issues.
?
和亚洲运营供应商质量经理、供应商质量工程师及主要供应商一起进行供应商质量改善活动,参与
p>
新供应商评估工作,以及供应商相关质量计划的审核及批准
;
Lead
Supplier
Quality
Improvement
activities
by
working
closely
with
Asia
Oprs
SQE
Manager,
SQE
and
major
suppliers;
as
well
as
participating
in
new
supp
lier
evaluation
and
Supplier
related
Quality
Plan
reviews
and
approvals
as
ap
propriate.
?
领导质量检验团队和检验行为确保其在运营中遵守质量和法
规要求
;
Lead
Quality
inspection
team
and
activities
to
meet
inspection
criteria
requir
ements
as
well
as
roving
audit
to
ensure
adherence
to
quality
and
regulatory
requirements
for
operations.
?
p>
很好的了解质量工具和
6-Sigma
方法
并可以利用质量工具来评估过程中的差异并推动质量改善活
动
;
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文档从网络中收集,已重新整理排版
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Understand
quality
tools/
6-Sigma
methodologies
well
and
able
to
evaluate
proc
ess
variances
and
drive
quality
improvement
utilizing
quality
control
tools.
?
紧密的和项目转移
/
新产品导入团队一起确保所有质量
工程的要求和检验要求的建立并满足产品要
求
;
Work
with
transfer/NPI
teams
closely
to
ensure
all
quality
engineering
require
ments
and
inspection
requirements
are
set
up
and
met
product
requirements.
?
管理和发展一个能干和专业的质量保证团队,包括目标管理和成本及费用的管理
;
Manage
and
develop
a
capable
and
professional
quality
assurance
team
including
target
management
and
expenses
dgets
management
.
?
和其他职能审核评估一样,对第三方和内部质量体系审核提
供支持
(FDA,
Notified
Body,
CFDA,
Corporate
Compliance
audit,etc);
Provide
support
for
3rd
party
and
internal
Quality
System
audits
(FDA,
Notifi
ed
Body,
CFDA,
Corporate
Compliance
audit,etc)
as
well
as
other
functional
au
dits/evaluations.
?
需要时提供健康危害评估或协调召回通知
;
Support
Health
Hazard
Evaluations
(HHE)
and
coordinates
on
recall
notices
as
necessary.
?
在质量问题中进行有效的沟通和发展识别并提供推荐的过程改善方案给管理层
< br>;
Communicates
significant
issues
or
developments
identified
during
quality
activi
ties
and
provides
recommended
process
improvements
to
management.
?
在产品质量的精益活动中提供指导和个人支持
;
Provides
leadership
and
personnel
support
for
lean
initiatives
related
to
qual
ity
of
product.
?
发展和维护一个精明强干的
QE/
QC
团队
;
Develop
and
maintain
a
capable
and
competent
QE/QC
team.
?
< br>和法规及相关团队一起发现现有作业流程中的漏洞,牵头来优化质量部的相关流程
;
Work
closely
with
RC
and
related
teams
to
capture
the
gaps
to
current
proce
dure/WI,
and
take
leader
to
optimize
those
documents
of
quality
functions
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文档从网络中收集,已重新整理排版
.word
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.
D
、资格要求
Job
Qualification:
?
本科或以上学历,机械工程或材料工程专业优先
;
Bachelors
degree
or
above,
Mechanical
engineering
or
material
engineering
major
preferred
?
在医疗设备行业或机加工行业中有
5
年以上质量
管理经验,有
6-Sigma
黑带背景优先
;
5
years
of
quality
management
experience
in
practical
medical
device
or
machi
ning
manufacturing
areas.
Certified
Six-Sigma
Blackbelt
is
preferred.
?
拥有质量体系知识,了解
FDA
和相关法规知
识优先。懂得如何用相关知识和经验进行实际应用,比
如
21
QSR
Part
820
and
ISO
13485:2003
)。
A
working
knowledge
of
Quality
Management
System
(ISO13485
or
QSR820
etc);
FD
A
and
regulations
knowledge
is
preferred;
and
how
to
interpret
and
monitor
t
hem
with
experience
or
knowledge
in
Quality
Systems
relating
to
21
QSR
Part
820
and
ISO
13485:2003.
?
能理解以下的工具并有执行的经验:
5S,
kaizen,
kanban,
value
stream
management,
poka-yokes,
SMED,
etc;
Understanding
and
implementation
experience
in
the
following
tools
is
required:
5S,
kaizen,
kanban,
value
stream
management,
poka-yokes,
SMED,
etc.
?
电脑操作技能,如
Excel
p>
、
Powerpoint
和
Word;
Computer
skills
required,
including
Microsoft
Excel,
Powerpoint
and
Word.
?
良好的个人职业操守
;
Professional
and
ethical
conduct
?
有很好的执行能力
;
Committed
to
strive
for
excellence
in
the
execution
of
required
responsibiliti
es
?
能不断提高英语交流能力和企业文化意识
;
Committed
to
continuously
improve
English
communication
skills
and
cultural
awa
reness
?
愿意为了能更好的行使工作职责而不断的去学习
.
Committed
to
continuously
learn
as
needed
to
perform
the
required
responsibili
ties
QE
A
汇报对象
Report
line
:
Group
Leader
B.
工作综述
Job
Function:
全面负责完成转移项目。转移项目组必须确保在项目转移完成
前能稳定生产。
The
overall
responsibility
of
this
position
is
to
develop
a
complete
transfer
package
for
handover
to
the
production
organization
in
JB.
The
transfer
tea
m
must
ensure
that
production
is
at
steady
state
before
the
transfer
is
com
plete.
?
全面负责各种质量问题的处理(外
部发送方投诉处理、内部重大
MRB
处理、每日
MRB
评审….)
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