Senior Quality Engineer - NPI & Metrology Leader

TOMZ Corporation; Big Lake (MN); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

TOMZ Corporation in Minnesota seeks a senior Quality Engineer to lead NPI quality initiatives, develop robust inspection plans, and mentor cross-functional teams. You will drive CAPA actions, oversee metrology programs (CMM/vision systems), and ensure GMP/GDT compliance while coordinating with customers.

Ideal candidates have 7+ years in regulated manufacturing, ASQ CQE/CRE, and strong statistical methods experience, with a background in medical device contexts.

Qualifications

• Regulated manufacturing industry experience in medical device sectors preferred.
• Experience leading programs or customer-facing projects and mentoring juniors.
• Ability to work in a fast-paced environment and self-start.

Responsabilités

• Author and execute Quality Plans, Control Plans, and Master Validation Plans for New Product Introduction.
• Manage risk files with cross-functional teams and customers.
• Lead inspection planning and process controls, including first article and production visual standards.
• Support Gage calibration review, management, and evaluation.
• Apply CAPA methodologies to resolve quality issues.
• Interface with customers and ensure timely deliverables.

Connaissances

Lead on a Program

Mentoring junior associate

Statistics techniques

GD&T

Process validation

Metrology

CMM programming

Vision System programming

ASQ CQE or CRE

Six Sigma Green or Black belt

DMIS programming certifications

MS Office (Visio, Project, Outlook, Wd

Formation

Bachelor's degree in Engineering, Manufacturing, or Business

Engineering degree with 7+ years of manufacturing quality experience (advanced metrology including CMM/ Vision System)

Outils

Solid Works

Unigraphics

Mastercam

Solid Edge

DMIS programming

Description du poste

TOMZ Corporation in Minnesota seeks a senior Quality Engineer to lead NPI quality initiatives, develop robust inspection plans, and mentor cross-functional teams. You will drive CAPA actions, oversee metrology programs (CMM/vision systems), and ensure GMP/GDT compliance while coordinating with customers.

Ideal candidates have 7+ years in regulated manufacturing, ASQ CQE/CRE, and strong statistical methods experience, with a background in medical device contexts.