Quality Product Release Specialist

Requisition ID:  32331  

 

At Terumo Blood and Cell Technologies, our 7,000+ global associates proud to come to work each day, knowing that what we do impacts the lives of patients around the world.

 

We make medical devices and related products that are used to collect, separate, manufacture and process various components of blood and cells. With our innovative technologies and service offerings, we touch a patient’s life every second of every day and are committed to continuing to increase the number of patients we serve.

 

With some of the best and brightest minds in the industry, an unmatched global footprint, comprehensive benefits and a distinct culture, Terumo Blood and Cell Technologies is a great place to work, grow and be part of a team that is focused on making a difference. Consider joining our team and unlock your potential.

JOB TITLE:  Quality Product Release Specialist

 

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.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

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

 

Experience

• Minimum 2 years experience.

• Requires experience in a manufacturing environment.

Skills

• Knowledge and use of relevant PC software applications and skills to use them effectively.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Demonstrated ability to routinely diagnose problems and recommend solutions through teamwork, failure mode analysis, and other analytical techniques.
• Develops or participates in the development of solutions to problems of moderate to intermediate complexity.