Quality Assurance Coordinator
Carehealth America Corporation Carehealth America Corporation Blue Earth, MN Blue Earth, MN Full-time Full-time $16 - $20 an hour $16 - $20 an hour 20 hours ago 20 hours ago 20 hours ago Quality Assurance Coordinator CareHealth America Corp.
(formerly EDI) was founded in 2004.
As the FDA-registered, cGMP Compliant and ISO 13485:
2016-certified U.
S.
manufacturer of DrugCheck onsite drugs of abuse screening devices, the company was named three times to the Inc.
5000 list of fastest growing companies in the U.
S.
Primary Role:
The Quality Assurance Coordinator will be responsible for ensuring that CareHealth America's products meet quality standards, testing new products to ensure compliance with standard procedures, assisting in product testing and calibration procedures, assisting in product documentation procedures, and assisting in the development of quality systems.
The Quality Assurance Coordinator will also assist in training new employees on standard operating procedures and assist in the implementation of quality systems.
The Quality Assurance Coordinator will also assist in the development of training programs for new employees as needed.
Essential Duties &
Responsibilities:
Conduct internal audits.
Responsible for coordinating with all departments to ensure they have all the necessary Quality Management System documents and all documents are properly stored.
Responsible for ensuring all Master documents and Obsolete documents are properly stored and controlled.
Review DHR and release product.
Responsible for reviewing and approving certain quality records.
Conduct complaint-related testing.
Provide the organization efficient, controlled accessibility of documents.
Manage the control of documents of external origin such as customer documents, ISO standards, and applicable regulations.
Facilitate the periodic review of documents to comply with Quality Management System requirements.
Ensure master documents meet the requirements.
Communicates with customers regarding complaints from the acknowledgement of complaint to closing summaries and manages Complaint Log.
Maintain and ensure accuracy of the Approved Supplier Log.
GUDID Labeler for FDA's GUDID database.
Prepare document changes for approval.
Maintain training records.
Assist the Quality Control Department as needed.
Handle initial customer complaints, provide customer support, and monitor customer satisfaction.
General administrative and clerical support as needed.
Inform the Senior Vice President of Administration and Compliance of customers issues, etc.
Other duties as assigned.
Job Type:
Full-time Pay:
$16.
00 - $20.
00 per hour
Benefits:
401(k) Dental insurance Flexible schedule Health insurance Paid time off Vision insurance Schedule:
Monday to Friday Ability to commute/relocate:
Blue Earth, MN 56013:
Reliably commute or planning to relocate before starting work (Required)
Experience:
ISO 9001:
1 year (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
(formerly EDI) was founded in 2004.
As the FDA-registered, cGMP Compliant and ISO 13485:
2016-certified U.
S.
manufacturer of DrugCheck onsite drugs of abuse screening devices, the company was named three times to the Inc.
5000 list of fastest growing companies in the U.
S.
Primary Role:
The Quality Assurance Coordinator will be responsible for ensuring that CareHealth America's products meet quality standards, testing new products to ensure compliance with standard procedures, assisting in product testing and calibration procedures, assisting in product documentation procedures, and assisting in the development of quality systems.
The Quality Assurance Coordinator will also assist in training new employees on standard operating procedures and assist in the implementation of quality systems.
The Quality Assurance Coordinator will also assist in the development of training programs for new employees as needed.
Essential Duties &
Responsibilities:
Conduct internal audits.
Responsible for coordinating with all departments to ensure they have all the necessary Quality Management System documents and all documents are properly stored.
Responsible for ensuring all Master documents and Obsolete documents are properly stored and controlled.
Review DHR and release product.
Responsible for reviewing and approving certain quality records.
Conduct complaint-related testing.
Provide the organization efficient, controlled accessibility of documents.
Manage the control of documents of external origin such as customer documents, ISO standards, and applicable regulations.
Facilitate the periodic review of documents to comply with Quality Management System requirements.
Ensure master documents meet the requirements.
Communicates with customers regarding complaints from the acknowledgement of complaint to closing summaries and manages Complaint Log.
Maintain and ensure accuracy of the Approved Supplier Log.
GUDID Labeler for FDA's GUDID database.
Prepare document changes for approval.
Maintain training records.
Assist the Quality Control Department as needed.
Handle initial customer complaints, provide customer support, and monitor customer satisfaction.
General administrative and clerical support as needed.
Inform the Senior Vice President of Administration and Compliance of customers issues, etc.
Other duties as assigned.
Job Type:
Full-time Pay:
$16.
00 - $20.
00 per hour
Benefits:
401(k) Dental insurance Flexible schedule Health insurance Paid time off Vision insurance Schedule:
Monday to Friday Ability to commute/relocate:
Blue Earth, MN 56013:
Reliably commute or planning to relocate before starting work (Required)
Experience:
ISO 9001:
1 year (Preferred) Work Location:
In person.
Estimated Salary: $20 to $28 per hour based on qualifications.
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