Engineer 2 - Global Supplier Quality - New Product Introduction & Supplier Excellence

Terumo BCT, Inc.•Denver, CO

1d•$81,700 - $102,100•Hybrid

About The Position

As a Supplier Quality Engineer II, you’ll play a critical role in ensuring supplier readiness and product success by partnering directly with suppliers to drive process reliability, consistency, and compliance from design transfer through product launch. In this highly collaborative role, you’ll apply your expertise in process controls, validation, auditing, CAPA investigations, and supplier development to proactively identify and resolve quality risks while strengthening scalable, standardized supplier quality practices. You’ll work cross‑functionally and independently, using sound judgment and creativity to adapt proven engineering methods, improve manufacturing capability, and elevate supplier performance—making this an ideal opportunity for a quality professional who thrives on ownership, problem‑solving, and building strong supplier partnerships that enable high‑quality, manufacturable products. The primary focus of this role will be to ensure suppliers are qualified, capable, and prepared to deliver compliant and manufacturable components prior to design transfer and product launch. This role works cross-functionally and directly with suppliers to improve process reliability, repeatability, controls, and resolution of quality issues, while contributing to standardized and scalable supplier quality processes.

Requirements

Bachelor’s degree or equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
Minimum 4 years of relevant experience.
Two years of GMP manufacturing experience in a regulated industry or similar field.
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.
An equivalent competency level acquired through a variation of these qualifications may be considered.

Nice To Haves

Bachelor of Science Degree in Engineering, preferred.

Responsibilities

Serves as the supplier quality representative on assigned NPD/NPI Core Teams.
Engages early in concept and design phases to assess supplier capability, capacity, and risk.
Provides Design for Manufacturability (DFM) and supplier readiness input to support production-scale feasibility.
Tracks and closes supplier-related deliverables and action items.
Supports supplier selection, evaluations, and qualification activities for components, OEM products, and contract manufacturing services.
Defines and executes component and process qualification strategies, including validation and verification activities.
Collaborates with suppliers to identify and close gaps related to process capability, validation, controls, or documentation.
Manages Supplier Corrective Action Requests (SCARs) and supports corrective and preventive action activities.
Drives supplier readiness and risk assessments prior to design transfer and launch.
Partners with Procurement, Operations, Manufacturing, and Quality to ensure effective handoff from development to production.
Approves disposition of nonconforming product and facilitates implementation of supplier product or process changes.
Monitors supplier quality performance using defined metrics and data analysis.
Works on-site at suppliers, as needed, to address quality or delivery concerns and support continuous improvement initiatives.
Applies statistical tools such as process capability analysis, equivalence testing, and measurement system analysis (e.g., Gage R&R).
Adheres to standardized global GSQ-NPI and Supplier Quality procedures, tools, and documentation requirements.
Maintains accurate and compliant project records, qualification reports, and technical documentation in accordance with regulatory expectations.
Contributes to the development, standardization, and continuous improvement of scalable supplier quality processes through lessons learned, kaizen activities, and cross-functional feedback.
Performs ISO 13485 and/or ISO 9001-based supplier audits and other supplier capability assessments.
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.
Works cooperatively and effectively across teams to achieve common goals and quality outcomes.