Engineer 2 - Supplier Quality

Requisition ID:  32728  

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.

Terumo Blood & Cell Technologies (TBCT) is currently seeking qualified candidates for the position of Supplier Quality Engineer II, which is responsible for working with Suppliers to improve process reliability, repeatability, controls and resolution of quality issues.  Supplier Quality Engineers must be proficient at process controls, project management, process validation and verification, test method validations, process improvement, supplier auditing, supplier management, and CAPA investigations.  Seeking candidates with strong quality improvement, supplier development, and process improvement skills. 

Work requires originality and judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria.  Performs work which requires a broad knowledge of precedents in the specialty area and a good knowledge of principles and practices of related specialties.  Duties are assigned to provide experience and familiarization with engineering methods, independent thinking, and company practices and policies.

ESSENTIAL DUTIES

• Supports the overall Supplier Quality Team in resolving critical quality issues and functions as a member of the Supplier Engineering Team working cross-functionally and proactively on supplier quality and management activities.  These activities include:
  • Supplier Development and Process Improvement
  • Supplier Auditing and Performance monitoring
  • Component, tooling, and process validations / verification
  • Test Method Validations and Gage Correlation.
  • Supplier Corrective Action Requests (SCARs) management
• Manages supplier quality performance, including corrective and preventive actions and performance metrics.
• Works on-site at supplier(s) to address quality or delivery concerns and develops an environment that facilitates continuous improvement.
• Approves disposition of nonconforming product and facilitates implementation of product/process changes.
• Performs ISO 13485 and or ISO 9001-based audits of suppliers and conducts other assessments of supplier capability.
• Analyzes data and applies statistical analysis including process capability, equivalence, and measurement system analysis (i.e. Gage R&R). Presents it in appropriate forums.
• Works well in cross-functional teams to prepare and review engineering/technical documents such as protocols, reports, specifications, drawings, and supplier provided documents.
• Collaborates with manufacturing, addressing quality & delivery issues that impact production.

• Follows company and department processes and makes recommendations on these processes.

• Works cooperatively and effectively in a team environment or across teams to achieve common goals and results.
• Knowledge of plastic injection molding, extrusion, thermoforming and other relevant manufacturing processes.
• Work assignments may require additional development or broadening of in-depth engineering skill(s).
• May work with manufacturing and other functional groups on manufacturing and regulatory compliance issues.

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.
• Bachelor of Science Degree in Engineering, preferred.

Experience

• Minimum 4 years of relevant experience.
• Two years of GMP manufacturing experience in a regulated industry or similar field.

Skills

• Project management and coordination with cross-functional team members.
• Understanding of GD&T, Gage R&R, and Correlation studies.
• Qualified Lead Auditor (ISO13485).
• Understanding of and adherence to GMP practices and FDA regulations.
• Continuous improvement mindset, e.g. LEAN, Six Sigma.
• Provides support for technicians, quality specialists, and management.
• Interfaces with staff, suppliers, and external subject matter experts to resolve technical issues.
• Knowledge and ability to implement FDA or regulatory requirements as necessary.
• Demonstrated ability to communicate effectively both verbally and in writing.
• Knowledge and use of relevant PC software applications and databases, and skills to use them effectively. 
• Solves moderately complex problems, identifying problems, generating alternatives and recommending solutions. 

-Or-

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

LOCATION

Littleton, Colorado - Opent to candidates wiling to relocate to the area. 

Travel

May require up to 20% travel based on business needs.

PHYSICAL REQUIREMENTS

• General Labor Environment requirements include use of personal protective equipment, reading, speaking, hearing, walking, bending, standing, stretching/reaching, hand/finger dexterity, and occasional lifting up to 50 pounds, or transporting up to 500 pounds via carts or mechanized equipment.
• 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:  $82,000.00 to $102,500.00  -  Salary to 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.