Site Validation Engineer - Medical Devices & Quality

Embecta Corp.; Holdrege (NE); On-site; USD 80,000 - 110,000; Full time

Job summary

Embecta Corp. in Holdrege, NE, seeks a Site Validation Engineer to lead validation initiatives in support of product design and manufacturing processes.

You will develop and maintain the Validation Master Plan, track schedules, and work with Quality Engineering and Quality Systems to ensure compliance. The role requires 3+ years in quality with validation experience, strong problem solving, and knowledge of GMP/ISO 13485.

Qualifications

• 3+ years in quality with validation and quality engineering responsibilities.
• Experience with medical device quality systems and GMP/ISO standards.
• Proficiency in statistical methods and problem-solving tools.
• Knowledge of 21 CFR 820 and ISO 13485.
• Six Sigma certification desired.

Responsibilities

• Lead validation initiatives in support of product design activities.
• Develop and maintain the Validation Master Plan and tracking schedule.
• Provide QA direction using root cause analysis, FMEA, and DOE.
• Provide training on validation processes and procedures.
• Approve protocols and reports for validation and change control.
• Support audits and drive continuous improvement with Lean Six Sigma.

Skills

Statistical methods

Problem solving

Quality engineering

Validation

Change control

Six Sigma

Documentation

Communication

Education

Bachelor of Science in Engineering

Tools

Minitab

MS Word

MS Excel

MS Project

Job description

Embecta Corp. in Holdrege, NE, seeks a Site Validation Engineer to lead validation initiatives in support of product design and manufacturing processes.

You will develop and maintain the Validation Master Plan, track schedules, and work with Quality Engineering and Quality Systems to ensure compliance. The role requires 3+ years in quality with validation experience, strong problem solving, and knowledge of GMP/ISO 13485.