Procurement Engineer - NPI, QA & Supplier Quality

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

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.