Quality Product Technician I

Requisition ID: 33079

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.

JOB TITLE: Quality Product Technician I -Shift 3 (Thursday through Saturday and every other Wednesday 5AM - 5:30 PM)

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.
• 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.
• Demonstrated knowledge of manufacturing protocols, statistical tools and methodology, continuous improvement techniques, and basic project management skills

-Or-

An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.

The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

Target Pay Range:$21.00to$27.00- Hourly pay rateto be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data
Target Bonus on Base:7.0%

At Terumo Blood and Cell Technologies, we provide competitive total reward offerings that consist of compensation, benefits, recognition, along with a wealth of other well-being, work-life and recognition programs which support in unlocking the potential for you and your family.Included in our expansive list of benefits offerings are multiple group medical, dental and vision plans, a robust wellness program, life insurance and disability coverages, also a variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.To help you save for retirement, we offer a 401(k) plan with a matching contribution and for work-life balance we have vacation and sick time programs for associates.For us, it's about protecting the personal welfare of our associates and their families, helping to achieve personal goals and offering those extra touches for convenience, security and overall peace of mind.

• Terumo Blood and Cell Technologies is part of Terumo Group, founded in 1921 and headquartered in Tokyo, Japan.
• In 2019, Terumo Blood and Cell Technologies reached $1 billion in revenue.
• We employ nearly 7,000 associates globally, with global headquarters in Lakewood, CO, U.S., and regional headquarters in Brussels, Buenos Aires, Singapore and Tokyo.
• We manufacture devices, disposable sets and solutions at our facilities in Belgium, India, Japan, Northern Ireland, the U.S. and Vietnam. Our global presence enables us to serve customers in more than 130 countries.
• Our core values help set our direction, guide our actions and keep us true to our corporate mission of contributing to society through healthcare.
  • Respect - Appreciative of others
  • Integrity - Guided by our mission
  • Care - Empathetic to patients
  • Quality - Committed to excellence
  • Creativity - Striving for innovation
• We contribute to the Leukemia and Lymphoma Society (LLS), raising $1.3 million USD since 2007.

We are proud to be an Equal Opportunity Affirmative Action Employer. All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, gender identity or expression, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.

Terumo Blood and Cell Technologies is committed to providing a safe, healthy and secure working environment.Our Colorado campus locations are tobacco-free workplaces,and we maintain a drug-free workplace and perform pre-employment substance abuse testing and detailed background verification.