Procurement Engineer

Tekgence Inc; Loveland (CO); On-site; USD 85,000 - 105,000; Full time

Job summary

Tekgence Inc in Loveland, CO is seeking a quality/ manufacturing engineer to support NPI, sustenance, and product transfer, ensuring GMP compliance and robust documentation.

You will plan and execute IQ/OQ/PQ protocols, participate in First Article testing, and maintain PPAP/APQP and supplier qualification records while collaborating across Engineering, R&D, Quality, Sourcing, and Operations.

Qualifications

• Experience supporting NPI, product sustenance, and product transfer.
• Proficiency creating ECNs, drawing updates, fixture designs, and digital work instructions.
• Experience developing and executing IQ/OQ/PQ equipment validation.
• Experience planning and evaluating First Article activities (FIT/FOU).
• Knowledge of CQP, CQR, PPAP, APQP, and supplier qualification docs.
• Experience managing supplier CAPA, deviations, audits, and supplier KPIs.
• Working knowledge of ASTM standards and equivalents.
• Strong cross-functional collaboration across Engineering, R&D, Quality, Sourcing, Supply Chain, Operations, and SQE teams.

Responsibilities

• Support NPI, sustenance, and transfer activities.
• Create ECNs, update drawings, fixtures, and digital work instructions.
• Review design intent, manufacturability, tolerances, GD&T, materials and inspection requirements.
• Develop and execute IQ/OQ/PQ protocols per cGMP/FDA requirements.
• Plan and perform First Article testing (FIT/FOU).
• Maintain CQP, CQR, PPAP, APQP, and supplier qualification documentation.
• Manage supplier CAPA, deviations, audits, and quality KPIs.
• Collaborate cross-functionally with Eng, R&D, Quality, Sourcing, and Supply Chain.

Skills

Cross-functional collaboration

Documentation discipline

Attention to detail

Problem solving

Tools

SolidWorks

Job description

Experience supporting NPI, product sustenance, and product transfer, including assembly procedures and manufacturing documentation.

Hands-on experience creating engineering change orders, change orders, drawing updates, fixture designs, and digital work instructions.

Proficiency in SolidWorks, with the ability to review design intent, manufacturability, tolerances, and engineering drawings, including GD&T, materials, and inspection requirements.

Experience developing and executing equipment validation protocols (IQ/OQ/PQ) in compliance with cGMP and FDA requirements.

Hands-on experience planning, executing, and evaluating First Article activities and performing fit, form, and function testing.

Experience completing and maintaining CQP, CQR, PPAP, APQP, and supplier qualification documentation.

Experience managing supplier CAPA, Product Deviation Notices, supplier process audits, audit documentation, and supplier quality KPIs.

Working knowledge of ASTM and equivalent international standards.

Strong cross-functional collaboration with Engineering, R&D, Quality, Sourcing, Supply Chain, Operations, and Supplier Quality Engineering teams