Engineer - Global Supplier Quality - Product Introduction & Supplier Excellence

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

Location: Lakewood, CO, US

Requisition : 34982

• 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.

• 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.

• 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.
• Understanding of and adherence to GMP practices and FDA regulations.
• 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.

Lakewood, Colorado - Onsite (hybrid) - Open to candidates willing to relocate to the area.

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

• 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…