Quality Product Technician I - 4th Shift

Requisition ID:  33156  

 

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. For Terumo, for Everyone, Everywhere.

 

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. Advancing healthcare with heart.

 

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. Join us and help shape wherever we go next. You create your future and ours.

 

Quality Product Technician I

4th shift Every other Wednesday, Thursday-Saturday

 

JOB SUMMARY

Quality Product Technicians are responsible for testing materials and finished products to ensure they conform to all applicable laws and company standards. Quality Product Technicians test products across the three stages of production (before, in-process, and final) to ensure quality levels are met. Quality Product Technicians review and approve 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.

 

ESSENTIAL DUTIES

• Perform inspections across all stages of production (raw materials, in-process, and final)
• Prepare and maintain test data for review
• Monitor production operations to ensure conformance to company specifications
• Evaluate data and draft reports, noting any relevant deviations from existing standards
• Identify areas for quality control improvement and implement new methods accordingly
• Working independently to coordinate and obtain all required documentation for a complete DHR
• Monitors and responds to SPC data as needed
• Communicate quality or compliance concerns with urgency
• Provides accurate and timely turnaround time for approval on product documentation and SAP transactions.
• Initiates Nonconformance reports and conducts bracketing and segregation of impacted product
• 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 manufacturing facilities in meeting Quality System and regulatory requirements.
• Maintains regulatory required records per record retention requirements.
• Involvement in internal and external quality audits regarding inspections, Device History Records, SAP transactions, and Policies/SOPs/WINS.
• Balance and prioritize essential daily tasks with longer term continuous improvement projects.

 

MINIMUM QUALIFICATION REQUIREMENTS

 

Education

Two-year technical degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.   Bachelor’s degree preferred. 

 

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.