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

About the role

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.

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.
• PARTNER 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, STANDARIZATION, 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.

Requirements

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

Qualifications

• 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.

Benefits

• 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.
• Multiple group medical, dental and vision plans.
• A robust wellness program.
• Lifetime life insurance and disability coverages.
• A variety of voluntary programs such as group accident, hospital indemnity, critical illness, pet insurance and much more.
• A 401(k) plan with a matching contribution.
• Vacation and sick time programs for associates.

Pay

Target Pay Range: $81,700.00 to $102,100.00 - Salary to be determined by the education, experience, knowledge, skills, and abilities of the applicant, internal equity, and alignment with market data

Schedule

Onsite (hybrid) - Open to candidates willing 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.

Location

Lakewood, Colorado

Company

Terumo BCT, Inc.

Equal Opportunity Employer

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

We are 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.