Senior Quality Engineer II – Medical Device Quality

Lancesoft; Warsaw (IN); Sur place; USD 90 000 - 120 000; Plein temps

Résumé du poste

Lancesoft is seeking a Sr Quality Engineer II in Warsaw, IN to drive quality practices across departments and suppliers. You will gather data, resolve issues, and lead projects with realistic timelines to ensure products meet established requirements.

Experience with ISO/QSR, FMEA, and GD&T is essential, as is familiarity with CMMs and optical comparators. A CQE/CRE certification is highly valued. This is a contract role with potential for ongoing work.

Qualifications

• B.S. in engineering or equivalent with QA focus.
• CQE or CRE preferred, with relevant device experience.
• 5–7 years in quality engineering, medical device preferred.

Responsabilités

• Gather data to solve quality problems and implement fixes.
• Lead audits, inspections, and testing to meet specs.
• Collaborate across departments with suppliers and regulatory bodies.

Connaissances

Teamwork

Blueprint reading

GD&T

QSR/ISO regs

FMEA

Product testing

CMMs

Optical comparators

Statistics

Process control

MS Office

Formation

B.S. in engineering

CQE certification

CRE certification

Outils

CMMs

Optical comparators

MS Office

Description du poste

Lancesoft is seeking a Sr Quality Engineer II in Warsaw, IN to drive quality practices across departments and suppliers. You will gather data, resolve issues, and lead projects with realistic timelines to ensure products meet established requirements.

Experience with ISO/QSR, FMEA, and GD&T is essential, as is familiarity with CMMs and optical comparators. A CQE/CRE certification is highly valued. This is a contract role with potential for ongoing work.