Engineer - Global Supplier Quality - Product Introduction & Supplier Excellence

Overview

Requisition : 34982

Terumo Blood and Cell Technologies employs 8,000+ global associates dedicated to impacting patients’ lives. We design and manufacture medical devices for blood and cell collection, separation, and processing. We are committed to advancing healthcare and inviting you to join a team that values ownership, quality, and collaboration.

Position:
Supplier Quality Engineer II
. The role partners with suppliers to drive process reliability, documentation, validation, and CAPA activities from design transfer through product launch. It emphasizes supplier qualification, readiness, and ongoing quality improvements to enable high-quality, manufacturable products.

• Serve as the supplier quality representative on assigned NPD/NPI Core Teams.
• Assess supplier capability, capacity, and risk early in concept and design phases.
• Provide Design for Manufacturability (DFM) and supplier readiness input to support production-scale feasibility.
• Track and close supplier-related deliverables and action items.
• Support supplier selection, evaluations, and qualification activities for components, OEM products, and contract manufacturing services.
• Define and execute component and process qualification strategies, including validation and verification activities.
• Collaborate with suppliers to address gaps in process capability, validation, controls, or documentation.
• Manage Supplier Corrective Action Requests (SCARs) and support corrective and preventive actions (CAPA).
• Drive supplier readiness and risk assessments prior to design transfer and launch.
• Partner with Procurement, Operations, Manufacturing, and Quality to ensure effective handoff from development to production.
• Approve disposition of nonconforming product and facilitate supplier changes.
• Monitor supplier quality performance using defined metrics and data analysis.
• Visit suppliers on-site as needed to address quality or delivery concerns and support continuous improvement.
• Apply statistical tools (e.g., process capability analysis, equivalence testing, Gage R&R).
• Adhere to GSQ-NPI and Supplier Quality procedures, tools, and documentation requirements.
• Maintain accurate project records, qualification reports, and technical documentation per regulatory expectations.
• Contribute to development and standardization of scalable supplier quality processes through lessons learned and cross-functional feedback.
• Perform ISO 13485 and/or ISO 9001-based supplier audits and other capability assessments.
• Demonstrate knowledge of plastic injection molding, extrusion, thermoforming, and related manufacturing processes.
• Collaborate with manufacturing and other functions on regulatory compliance issues as needed.
• Work cooperatively across teams to achieve quality outcomes.

• Bachelor's degree or equivalent experience;
  Bachelor of Science in Engineering preferred.

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

• Project management and cross-functional coordination.
• Understanding of GD&T, Gage R&R, and correlation studies.
• Qualified Lead Auditor (ISO
  13485).
• Understanding of GMP practices and FDA regulations.
• Continuous improvement mindset (LEAN, Six Sigma).
• Supporting technicans, quality specialists, and management.
• Interfaces with staff, suppliers, and external SMEs to resolve technical issues.
• Knowledge to implement FDA or regulatory requirements as necessary.
• Effective verbal and written communication.
• Proficiency with relevant PC software and databases.
• Ability to solve moderately complex problems and recommend solutions.

Or An equivalent competency level through similar qualifications may be considered.

Lakewood, Colorado — onsite (hybrid). Open to candidates willing to relocate.

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

• General labor environment: PPE, reading, speaking, hearing, walking, bending, standing, stretching, dexterity, and occasional lifting up to 50 pounds (or transporting up to 500 pounds via carts or mechanized equipment).
• Physical demands are representative of essential duties.
• Reaso…