HI,

Hope you are doing great!

This is Harry from Dynamic Enterprise Solutions. We have an urgent requirement 
with one of our Direct clients (No hidden Layers) , please review below job 
description and let me know your interest



Position ID: DYESAB00026201

Title: Quality Assurance Engineer
Tenure: 6 months+
Location: Onsite at least 3 days per week Temecula, (or) Santa Clara,  
California

Rate: $ 45/HR (max)



US Citizens, GC, EAD only – C2H position



Locals Preferred -  Onsite at least 3 days per week



Description:

Must have or will be rejected
Medical device experience background
Need some experience not looking for someone who is green right out of school 
or uses intern as job exp

Looking for
understand compliance, design process, validation, technical background, write 
protocol, test reports.
Quality of the person high profile
Need someone to hit the ground running


MAIN PURPOSE OF ROLE

Summarize the main purpose of the role.

Interpret applicable internal and external requirements and translate to 
produce documents such as procedures and partnership agreements that are in 
line with the Quality System. Define process improvements to ensure consistent 
implementation of internal requirements and external laws, regulations, 
guidance and standards.





MAIN RESPONSIBILITIES

• Identify internal requirements and external laws, regulations, guidance and 
standards (LRGS) applicable to one or more of division's quality systems

• Ensure internal activities and external partnership activities meet 
applicable regulations and quality standards including FDA QSR and ISO 9001/ 
ISO 13485

• Ensure external partnership activities meet applicable regulations and 
quality standards including FDA QSR and ISO 9001/ISO 13485

• Interpret applicable internal requirements and external LRGS and incorporate 
into requirements for use in business processes internally or with external 
partners

• Maintain and communicate monthly metrics

• Review and approval of product design changes and Quality System documentation

• Maintain external partner files

• Create Quality System and/or external partnership related documents

• Review external partnership assessment forms and assist in execution of 
onboarding and maintenance activities

• Participate in external inspection/audit activities

• Perform other duties as assigned by Management





QUALIFICATIONS

Education Level Major/Field of Study Or

Bachelors Degree (± 16 years) LifeSciences, Physical Sciences, Engineering 
discipline or equivalent technical degree

☒ an equivalent combination of education and work experience

Experience/Background

Experience Experience Details

Minimum 2 years







Thanks & Regard’s

Harry John
Dynamic Enterprise Solutions Inc
1801 Hicks Rd, unit A
Rolling Meadows, IL -60008
(847) 701-5896 /© 224-635-0898


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