- W-2 Open Positions Need to be Filled Immediately. Consultant must be on our company payroll, Corp-to-Corp (C2C) is not allowed.
Job ID:
J53093
Specialized Area:
Quality Analyst
Job Title:
Senior Quality Analyst/Engineer
Location:
Madison,WI
Duration:
10 Months
Domain Exposure:
Healthcare, IT/Software
Work Authorization:
US Citizen, Green Card, OPT-EAD, CPT, H-1B,
H4-EAD, L2-EAD, GC-EADClient:
To Be Discussed Later
Employment Type:
W-2 (Consultant must be on our company payroll. C2C is not allowed)
Bench Recruiter:
Ariana_Robert
Job Description :
Develop and maintain quality system processes, including metrics reporting and tracking
Manage CAPA initiation, review, surveillance, and reporting
Facilitate the site Quality Management reviews
Facilitate and lead the site Change Management process
Support and lead root cause analyses through cross functional team involvement
Leading Good Documentation Practice training and Quality on the Floor coordination and performance
Interpret and properly apply all applicable regulatory requirements
Coordinate and provide direct support for facility audits by internal and external entities
Manage data collection and reporting when product recalls are required
Perform trending of Quality Systems to support FDA and Management reviews
Improve quality culture through site initiatives and improve existing procedures to better align with regulatory requirements
Review and approval of procedures, protocols, reports, etc., as required.
Department specific/Non-essential responsibilities:
Filing and management of documentation when required
Supporting other Quality System Functions
This role may be required to lead personnel (inside and outside) the Quality organization in support of the business need
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Amtex is an equal opportunity employer inclusive of female, minority, disability and veterans, (M/F/D/V). Hiring, promotion, transfer, compensation, benefits, discipline, termination and all other employment decisions are made without regard to race, color, religion, sex, sexual orientation, gender identity, age, disability, national origin, citizenship/immigration status, veteran status or any other protected status. Amtex will not make any posting or employment decision that does not comply with applicable laws relating to labor and employment, equal opportunity, employment eligibility requirements or related matters. Nor will Amtex require in a posting or otherwise U.S. citizenship or lawful permanent residency in the U.S. as a condition of employment except as necessary to comply with law, regulation, executive order, or federal, state, or local government contract



