Quality Engineer II — Medical Devices & Continuous Improvement

1710 embecta Medical I LLC; Holdrege (NE); On-site; USD 70,000 - 90,000; Full time

Job summary

embecta is seeking a Quality Engineer II to support new product development and sustaining activities for medical devices. You will work with quality management, operations, suppliers, and embecta associates to ensure compliance with quality policies, design controls, and regulatory requirements throughout product lifecycle.

Responsibilities include applying quality engineering tools (RCA, FMEA, validation, DOE), contributing to continuous improvement, and coordinating validation and change

Qualifications

• B.S. degree in Engineering (Industrial, Mechanical) or similar.
• 3+ years of quality experience including validation and quality engineering responsibilities.
• Certified Quality Engineer and Certified Quality Auditor (preferred).

Responsibilities

• Support the plant on assigned product initiatives with technical expertise and determine resource needs to accomplish goals.
• Provide critical quality engineering direction with RCAs, FMEAs, risk mitigation, validation, and DOE/tools.
• Apply a moderate level of technical principles and quality sciences/tools.
• Develop solutions to routine problems of moderate scope.
• Maintain alignment to quality policies and practices through sound QA principles.

Skills

Root cause analysis

FMEA

Risk mitigation

Validation

DOE

Process improvement

Measurement systems analysis

MS Office

Statistical methods

Project management

Education

B.S. in Engineering (Industrial or Mechanical)

Tools

Minitab

MS Word

Excel

MS Project

Job description

embecta is seeking a Quality Engineer II to support new product development and sustaining activities for medical devices. You will work with quality management, operations, suppliers, and embecta associates to ensure compliance with quality policies, design controls, and regulatory requirements throughout product lifecycle.

Responsibilities include applying quality engineering tools (RCA, FMEA, validation, DOE), contributing to continuous improvement, and coordinating validation and change