Quality Engineering Lead - Medical Devices | ISO/QSR

Lancesoft; Warsaw (IN); On-site; USD 70,000 - 90,000; Full time

Job summary

Lancesoft in the United States is seeking a Quality Engineer to gather relevant data, analyze issues, and drive solutions across departments. You will participate in audits, inspections, and tests to ensure products meet established requirements and standards, working with suppliers and experts outside Lancesoft to implement quality goals.

Your responsibilities include evaluating processes, establishing quality plans, monitoring performance, and applying ISO/QSR requirements.

Qualifications

• B.S. in engineering or equivalent with CQE certification preferred.
• CQE certification is encouraged.
• 5–7 years of quality engineering experience required.
• Medical device experience preferred.

Responsibilities

• Plan and lead quality projects ensuring conformance to requirements.
• Establish quality plans for equipment and processes.
• Audit, inspect, and test activities to verify standards.
• Collaborate with multiple departments and suppliers to meet Client quality goals.

Skills

Teamwork

Deadline-driven

Written & oral communication

Blueprint reading

GD&T

QSR/ISO compliance

FMEA

Product testing methods

Statistical analysis

Education

B.S. in engineering or related field (CQE preferred)

CQE certification

CRE certification

Tools

MS Office Suite

Optical comparators

CMMs

Job description

Lancesoft in the United States is seeking a Quality Engineer to gather relevant data, analyze issues, and drive solutions across departments. You will participate in audits, inspections, and tests to ensure products meet established requirements and standards, working with suppliers and experts outside Lancesoft to implement quality goals.

Your responsibilities include evaluating processes, establishing quality plans, monitoring performance, and applying ISO/QSR requirements.