Quality Engineering Lead - Medical Devices & ISO

US Tech Solutions, Inc.; Warsaw (IN); On-site; USD 90,000 - 120,000; Full time

Job summary

US Tech Solutions, Inc. is seeking a Quality Engineer to gather and apply data to solve quality-related problems, lead projects, and ensure products conform to established standards through audits and testing.

You will interact with multiple departments, suppliers, and external experts to implement quality goals. The role requires strong team collaboration, excellent communication, and a solid understanding of statistics, GD&T, and regulatory requirements.

Qualifications

• B.S. in engineering or equivalent with CQE certification preferred.
• CQE or CRE certifications preferred.
• 5–7 years of experience in a Quality Engineering role, medical device preferred.

Responsibilities

• Evaluating process methods and equipment to meet performance and quality requirements.
• Establishing quality plans for equipment and processes for product performance needs.
• Monitoring performance of processes against standards.
• Applying ISO and QSR requirements to processes and supplier relationships.
• Assisting Manufacturing, Sourcing and Development with regulatory interpretations.
• Developing and maintaining department and project budgets.

Skills

Quality engineering

Teamwork

Deadline oriented

Written and oral communication

Statistics

Process control

GD&T

FMEA

Product testing

CMMs

Education

B.S. in engineering

CQE certification

CRE certification

Tools

MS Office

Blueprint reading

Geometric Dimensioning & Tolerancing

CMMs

Optical comparators

FMEA

Product testing methods

Job description

US Tech Solutions, Inc. is seeking a Quality Engineer to gather and apply data to solve quality-related problems, lead projects, and ensure products conform to established standards through audits and testing.

You will interact with multiple departments, suppliers, and external experts to implement quality goals. The role requires strong team collaboration, excellent communication, and a solid understanding of statistics, GD&T, and regulatory requirements.