Senior Quality Engineer - Medical Devices Leader

Aequor; Warsaw (IN); Presencial; USD 85.000 - 120.000; Jornada completa

Descripción de la vacante

Aequor is seeking a seasoned Quality Engineer in Indiana to ensure products meet all quality and regulatory standards. You will evaluate processes, develop QA plans, and lead cross‑functional teams to drive continuous improvement in a medical device environment.

The role requires 5–7 years in quality engineering, a B.S. in engineering with CQE/CRE preferred, and hands-on experience with ISO, QSR, GD&T, and CMMs. Strong collaboration with suppliers and internal departments is essential.

Formación

• B.S. in engineering or equivalent with CQE certification preferred.
• 5-7 years of Quality Engineering experience, medical device experience preferred.
• CQE or CRE certification is an asset.

Responsabilidades

• Evaluate process methods and equipment to meet performance and quality requirements.
• Establish quality plans for equipment and processes.
• Monitor performance of processes to standards.
• Apply ISO and QSR requirements to processes and suppliers.
• Collaborate with suppliers on new product introductions to ensure quality.
• Assist Manufacturing, Sourcing and Development with regulatory interpretations.
• Develop and maintain department and project budgets.
• Note: duties may vary and are not exhaustive.

Conocimientos

Team collaboration

Quality engineering

Data analysis

GD&T

Regulatory knowledge

Educación

B.S. in engineering

CQE certification preferred

Herramientas

CMMs

Optical comparators

Blueprint reading

Descripción del empleo

Aequor is seeking a seasoned Quality Engineer in Indiana to ensure products meet all quality and regulatory standards. You will evaluate processes, develop QA plans, and lead cross‑functional teams to drive continuous improvement in a medical device environment.

The role requires 5–7 years in quality engineering, a B.S. in engineering with CQE/CRE preferred, and hands-on experience with ISO, QSR, GD&T, and CMMs. Strong collaboration with suppliers and internal departments is essential.