Quality Assistant (8300766)

American Cybersystems, Inc. (ACS Group) Neenah, WI

Title:                     Quality Assistant (8300766)

Location:             10000062 Neenah - Cold Spring Facility 1050 Cold Spring Road Neenah WI 54956 United States

Duration:             12+ Months

Shift:                    7 am-3 pm

 

Description: The Quality Associate provides support for executing Quality System activities in all areas of the plant.

Accountabilities: Essential duties and responsibilities include the following. Other duties may be assigned.

• Perform work in a safe manner.

• Properly store and maintain documentation to ensure easy retrieval of data and also protect proprietary information relative to quality. Document results and reports required by KC policy to ensure effective communication and provide the necessary FDA and legal requirements.

• Communicate effectively at all levels of the organization. Communications should be prompt, complete, candid and clear.

• Conduct complaint investigations

• Scan device history records and arrange for records to be stored at 3rd party facility

• Conduct Trial bay monitoring

• Red event tracking and Quality Nonconformance initiator

• Demonstrate a strong degree of knowledge and skill in quality/regulatory related practices and systems.

• Support the following Quality Systems following defined practices: Control of Non-Conforming Product, Change Management, and Product Complaint Handling, Document/ Record Control, and Training.

 

Qualifications:

• Demonstrated achievement of individual results.

• Problem solving

• Document management

• Complaint management

• Strong communication skills (written and oral).

• Strong Organization/Time-management skills.

• Ability to work independently or as part of a team.

• Willingness and Ability to teach others.

• Proficient in using basic computer software (Microsoft Office applications).

• SAP experience (desired but not required)


Neenah WI 54956 United States

Duration:             12+ Months

Shift:                    7 am-3 pm

 

Description: The Quality Associate provides support for executing Quality System activities in all areas of the plant.

Accountabilities: Essential duties and responsibilities include the following. Other duties may be assigned.

• Perform work in a safe manner.

• Properly store and maintain documentation to ensure easy retrieval of data and also protect proprietary information relative to quality. Document results and reports required by KC policy to ensure effective communication and provide the necessary FDA and legal requirements.

• Communicate effectively at all levels of the organization. Communications should be prompt, complete, candid and clear.

• Conduct complaint investigations

• Scan device history records and arrange for records to be stored at 3rd party facility

• Conduct Trial bay monitoring

• Red event tracking and Quality Nonconformance initiator

• Demonstrate a strong degree of knowledge and skill in quality/regulatory related practices and systems.

• Support the following Quality Systems following defined practices: Control of Non-Conforming Product, Change Management, and Product Complaint Handling, Document/ Record Control, and Training.

 

Qualifications:

• Demonstrated achievement of individual results.

• Problem solving

• Document management

• Complaint management

• Strong communication skills (written and oral).

• Strong Organization/Time-management skills.

• Ability to work independently or as part of a team.

• Willingness and Ability to teach others.

• Proficient in using basic computer software (Microsoft Office applications).

• SAP experience (desired but not required)