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Job Requirements of Quality Engineer II:
-
Employment Type:
Full-Time
-
Location:
Saint Paul, MN (Onsite)
Do you meet the requirements for this job?
Quality Engineer II
Generis Tek Inc.
Saint Paul, MN (Onsite)
Full-Time
Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address can be reached on #
630-576-1932
.We have Contract role Quality Engineer for our client at Saint Paul, MN. Please let me know if you or any of your friends would be interested in this position.
Position Details:
Quality Engineer - Saint Paul, MN
Location : Saint Paul, MN - 55112
Project Duration : 6+ Months Contract
Pay Rate : $48/hour on W2
Job Description:
Description:
Quality Engineer II -
St. Paul : 1225 Old Highway 8 NW 100 percent onsite
Days/Hours: Mon – Friday 8:00am to 5:00pm
Must come with Medical Device Quality experience and be able to start contributing quickly. Training will be provided on Abbott systems, but foundational medical device knowledge is required.
Key Responsibilities
Support Quality for software development, manufacturing, operations, and engineering teams
Review/approve SDLC documents
Lead Hazard Analysis activities
Assist with SOPs, Work Instructions, and occasional training
Occasionally write/execute test protocols and reports
Required Qualifications
Medical Device Quality experience (Ops or Manufacturing)
Strong working knowledge of FDA/ISO regulations (13485, 14971, etc.)
Ability to ramp up quickly
3–5 years’ experience
Screening questions:
- How many years of Medical Device Quality experience do you have?
- Which regulations have you worked with: FDA 21 CFR 820, ISO 13485, ISO 14971?
- Have you performed or led Hazard Analysis / Risk Management activities?
- Do you have experience reviewing or approving SDLC documents?
- Are you available to work 100% onsite in St. Paul, MN and start ASAP?
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Monu Karwasara at email address can be reached on #
630-576-1932
.About generis tek: generis tek is a boutique it/professional staffing based in Chicago land. We offer both contingent labor & permanent placement services to several fortune 500 clients nationwide. Our philosophy is based on delivering long-term value and build lasting relationships with our clients, consultants and employees. Our fundamental success lies in understanding our clients’ specific needs and working very closely with our consultants to create a right fit for both sides. We aspire to be our client has most trusted business partner.
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