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System Engineering (Quality and regulatory)
Plano, TX
Plano
TX
75094
Date
: Feb-14-19
2019-02-14
2020-02-14
System Engineering (Quality and regulatory)
Plano, TX
Feb-14-19
2019-02-14
2020-02-14
Work Authorization
US Citizen
GC
H1B
GC EAD, L2 EAD, H4 EAD, TN EAD
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect, Senior
Rate/Salary ($)
:
DDOE
Duration
:
6 months
Sp. Area
:
QA / Testing
Sp. Skills
:
x-Other
Consulting / Contract
Third Party OK
CONTRACTOR
Required Skills
:
ISO, Quality, Regulatory,
Preferred Skills
:
Domain
:
Work Authorization
US Citizen
GC
GC EAD, L2 EAD, H4 EAD, TN EAD
H1B
Preferred Employment
Corp-Corp
W2-Permanent
W2-Contract
1099-Contract
Contract to Hire
Job Details
Experience
:
Architect, Senior
Rate/Salary ($)
:
DDOE
Duration
:
6 months
Sp. Area
:
QA / Testing
Sp. Skills
:
x-Other
Consulting / Contract
Third Party OK
CONTRACTOR
Required Skills
:
ISO, Quality, Regulatory,
Preferred Skills
:
Domain
:
Talent Junction LLC
San Jose, CA
Post Resume to
View Contact Details &
Apply for Job
Job Description
:
Title: System Engineering (Quality and regulatory)
Location: Plano, Texas
Required Experience/Skills:
- At-least 5-6 years in medical quality and regulatory environment
- Ability to work as a SME and ability to undertake MDR service offering
- Ability to understand product functionality and identify associated product and process standards needed for it compliance in various market like 510K, EC and Japan markets.
- Experience in the product standards for verifying whether the compliance of the product is completed in it verification stage.
- In-depth expertise in application of ISO 13485 and ISO 14971.
- Working knowledge of ISO 60601-1-X, ISO 62304, ISO 62366, brief knowledge of ISO 60601-2-X standards
- Standards for biocompatibility ISO 10993, packaging, transport and sterility.
- Understanding of clinical parameters associated with product.
- Understanding of labelling requirements as per MDR/UDI, tools to create them.
- Thorough understanding and experience of manufacturing environment and commercial segment of medical devices.
- Exposure to various PLMs and commonly used tools in medical device industry.
- Astute technical document authoring capabilities.
- Excellent Quality Assurance skills.
Client :
Confidential
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