Quality Release Coordinator

Job summary:

Working under minimal supervision, reviews and approves DHRs (Device History Records) and other records for finished disposables and equipment devices to ensure they meet established regulatory and quality guidelines prior to release for sale. Release Coordinators also review, approve, and coordinate special release scenarios such as QC Holds, Controlled Distribution, and Control of Distribution SAP transactions, where appropriate.

Essential duties:

• Working independently to coordinate and obtain all required documentation for a complete DHR.
• Provides accurate and timely turnaround time for approval on product release documentation and SAP release transactions.
• Responsible for Controlled Distribution, Control of Distribution and Quality Control Holds.
• Supports internal efforts to improve timeliness and ensure product quality to external customers.
• Interprets, executes, and recommends modifications to operating policies, SOPs, and WINs, where appropriate.
• Supports customer requests for established product certificates (Certificates of Compliance).
• Updates and maintains all product release indices, where appropriate.
• Supports non-US based facilities in meeting Quality System and regulatory requirements.
• Maintains regulatory required records per record retention requirements.
• Involvement in internal and external quality audits regarding Release paperwork, SAP transactions, and Policies/SOPs/WINS.
• Balance and prioritize essential daily tasks with longer term continuous improvement projects within the Release Coordinator scope.

Education:

• Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Licenses or certifications:

• N/A

Experience:

• Minimum 2 years’ experience.
• Requires experience in a manufacturing environment.

Job summary:

Working under minimal supervision, reviews and approves DHRs (Device History Records) and other records for finished disposables and equipment devices to ensure they meet established regulatory and quality guidelines prior to release for sale. Release Coordinators also review, approve, and coordinate special release scenarios such as QC Holds, Controlled Distribution, and Control of Distribution SAP transactions, where appropriate.

Essential duties:

• Working independently to coordinate and obtain all required documentation for a complete DHR.
• Provides accurate and timely turnaround time for approval on product release documentation and SAP release transactions.
• Responsible for Controlled Distribution, Control of Distribution and Quality Control Holds.
• Supports internal efforts to improve timeliness and ensure product quality to external customers.
• Interprets, executes, and recommends modifications to operating policies, SOPs, and WINs, where appropriate.
• Supports customer requests for established product certificates (Certificates of Compliance).
• Updates and maintains all product release indices, where appropriate.
• Supports non-US based facilities in meeting Quality System and regulatory requirements.
• Maintains regulatory required records per record retention requirements.
• Involvement in internal and external quality audits regarding Release paperwork, SAP transactions, and Policies/SOPs/WINS.
• Balance and prioritize essential daily tasks with longer term continuous improvement projects within the Release Coordinator scope.

Education:

• Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Licenses or certifications:

• N/A

Experience:

• Minimum 2 years’ experience.
• Requires experience in a manufacturing environment.

Job summary:

Working under minimal supervision, reviews and approves DHRs (Device History Records) and other records for finished disposables and equipment devices to ensure they meet established regulatory and quality guidelines prior to release for sale. Release Coordinators also review, approve, and coordinate special release scenarios such as QC Holds, Controlled Distribution, and Control of Distribution SAP transactions, where appropriate.

Essential duties:

• Working independently to coordinate and obtain all required documentation for a complete DHR.
• Provides accurate and timely turnaround time for approval on product release documentation and SAP release transactions.
• Responsible for Controlled Distribution, Control of Distribution and Quality Control Holds.
• Supports internal efforts to improve timeliness and ensure product quality to external customers.
• Interprets, executes, and recommends modifications to operating policies, SOPs, and WINs, where appropriate.
• Supports customer requests for established product certificates (Certificates of Compliance).
• Updates and maintains all product release indices, where appropriate.
• Supports non-US based facilities in meeting Quality System and regulatory requirements.
• Maintains regulatory required records per record retention requirements.
• Involvement in internal and external quality audits regarding Release paperwork, SAP transactions, and Policies/SOPs/WINS.
• Balance and prioritize essential daily tasks with longer term continuous improvement projects within the Release Coordinator scope.

Education:

• Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.

Licenses or certifications:

• N/A

Experience:

• Minimum 2 years’ experience.
• Requires experience in a manufacturing environment.