Remote Supplier Quality Engineer II - Medical Devices

Us Tech Solutions; Warsaw (IN); À distance; USD 70 000 - 100 000; Plein temps

Résumé du poste

US Tech Solutions is seeking a Quality Engineer to drive data-driven problem solving, ensuring products meet requirements and coordinating audits and testing across departments. You will collaborate with suppliers and external experts to implement quality goals and improve processes.

The role emphasizes teamwork, adherence to ISO/QSR standards, and applying statistical methods, FMEA, and measurement techniques such as CMMs and optical comparators.

Qualifications

• Bachelor’s in engineering or equivalent with CQE certification preferred.
• 3–5 years in quality engineering, medical device preferred.
• Knowledge of ISO and QSR regulations; experience with audits and testing.
• Experience collaborating with suppliers and cross-functional teams.
• Strong problem solving and data analysis skills.

Responsabilités

• Evaluating process methods and equipment to meet quality requirements.
• Establishing quality plans for equipment and processes for general and specific product performance needs.
• Monitoring performance of processes to standards.
• Applying ISO and QSR requirements to processes and procedures for Client and outside suppliers.
• Working with suppliers on new product introduction to insure that quality and performance requirements are fulfilled.
• Assisting Manufacturing, Sourcing and Development in the interpretation and application of regulations.
• Developing and maintaining department and project budgets.

Connaissances

Blueprint reading

Geometric dimensioning and tolerancing

QSR/ISO regulations

FMEA

Design assurance

Statistics and process control

Communication

Product testing methods

CMMs

Optical comparators

Formation

Bachelor’s in engineering

CQE certification

CRE certification

Outils

CMMs

Optical comparators

Microsoft Office

Description du poste

US Tech Solutions is seeking a Quality Engineer to drive data-driven problem solving, ensuring products meet requirements and coordinating audits and testing across departments. You will collaborate with suppliers and external experts to implement quality goals and improve processes.

The role emphasizes teamwork, adherence to ISO/QSR standards, and applying statistical methods, FMEA, and measurement techniques such as CMMs and optical comparators.