Quality Engineer II - Medical Devices, Validation & NPD

Embecta Corp.; Holdrege (NE); On-site; USD 65,000 - 90,000; Full time

Job summary

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. We are seeking a Quality Engineer II to support new product development and sustaining activities under the Quality Engineering Manager.

You will apply root cause analysis, FMEAs, risk mitigation, validation, DOE, and process improvement tools to ensure products meet corporate and regulatory standards, while collaborating with suppliers, operations, and cross-functional teams.

Qualifications

• BS degree required in engineering (Industrial or Mechanical preferred).
• 3+ years quality experience including validation and quality engineering responsibilities.
• CQE/CQA certification preferred.

Responsibilities

• Support the plant on assigned product initiatives with technical expertise and determine required resources to meet project goals.
• Provide quality engineering direction to Product development projects using established quality tools.
• Apply statistical methods, risk analysis, validation, DOE and problem-solving techniques to enable continuous improvement.
• Develop solutions to routine problems of moderate scope and complexity.
• Approve protocols and reports for validation and change control activities to ensure compliance.

Skills

Quality engineering

Validation

Statistical analysis

Root cause analysis

FMEA

DOE

Process improvement

Education

B.S. in Engineering

Tools

Minitab

MS Excel

MS Word

MS Project

Job description

embecta is a global medical device company with a 100-year legacy in insulin delivery and diabetes care. We are seeking a Quality Engineer II to support new product development and sustaining activities under the Quality Engineering Manager.

You will apply root cause analysis, FMEAs, risk mitigation, validation, DOE, and process improvement tools to ensure products meet corporate and regulatory standards, while collaborating with suppliers, operations, and cross-functional teams.