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Quality Consultant II

Job Description

Title:                     Quality Consultant II

Location:             Neenah WI 54956

Duration:            4 Months



Position Purpose:

Provides Quality/Regulatory support for Post Market Surveillance team while ensuring compliance to established procedures and processes – including complaint handling and adverse event reporting.


Customers:

Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Legal, Marketing, Consumer Services


Job Requirements


Position Specific Accountabilities:

1)            Executes assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Final Review, Sample Evaluation, and Flow to Work to assist others as needed.

2)            Perform Decision Tree Determination and drafting of adverse event reports for regulatory. 

3)            Achieves and maintains required competence level for Medical Device Reporting.

4)            Maintains relationships with Consumer Services, including reporting of errors, troubleshooting, and coordinating complaint handling activities and improvements.

5)            Helps execute CAPAs and QNCs.

6)            Complies with QMS, ISO, FDA GMP's, and Health Canada requirements.

7)            Provides Post-Market Surveillance support to Mills and/or Product Forms via Standard Work, data analysis, and communication. 



Job Snapshot

Location US-WI-Neenah
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type
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Company Overview

American Cybersystems, Inc. (ACS Group)

ACS Group provides services to Fortune 1000 companies across various industry verticals. With a proven track record of managing project demands while improving the efficiency, productivity and profitability of new and existing projects through process improvement, ACS Group is consistently recognized for identifying and implementing strategic solutions that create and preserve long-term business value. Learn More

Contact Information

US-WI-Neenah
Gupta Swati
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Snapshot
American Cybersystems, Inc. (ACS Group)
Company:
US-WI-Neenah
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Store Type:

Job Description

Title:                     Quality Consultant II

Location:             Neenah WI 54956

Duration:            4 Months



Position Purpose:

Provides Quality/Regulatory support for Post Market Surveillance team while ensuring compliance to established procedures and processes – including complaint handling and adverse event reporting.


Customers:

Operations, Corporate Quality Assurance, Regulatory Affairs, Product Safety, Research & Engineering, Packaging, Legal, Marketing, Consumer Services


Job Requirements


Position Specific Accountabilities:

1)            Executes assigned Post-Market Surveillance activities, including Complaint Assessment, Investigation, Trending/Reporting, Final Review, Sample Evaluation, and Flow to Work to assist others as needed.

2)            Perform Decision Tree Determination and drafting of adverse event reports for regulatory. 

3)            Achieves and maintains required competence level for Medical Device Reporting.

4)            Maintains relationships with Consumer Services, including reporting of errors, troubleshooting, and coordinating complaint handling activities and improvements.

5)            Helps execute CAPAs and QNCs.

6)            Complies with QMS, ISO, FDA GMP's, and Health Canada requirements.

7)            Provides Post-Market Surveillance support to Mills and/or Product Forms via Standard Work, data analysis, and communication. 



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