Senior Site Validation Engineer - Med Devices & Quality

Regulatory Jobs; Holdrege (NE); On-site; USD 75,000 - 110,000; Full time

Job summary

embecta, a global medical device company, is seeking a Site Validation Engineer in Nebraska to execute validation initiatives supporting product design and maintain the validation program. You will collaborate with Quality Systems and Quality Engineering to uphold rigorous standards and drive improvements.

The role requires a BS in Engineering and 3+ years of quality/validation experience, with strong RCA, DOE, and regulatory knowledge.

Qualifications

• BS in Engineering or related field required.
• 3+ years Quality/Validation experience.
• Experience with GMP/QA processes in medical device industry.

Responsibilities

• Execute and implement site validation initiatives for product design.
• Develop and maintain Validation Master Plan and tracking.
• Provide quality engineering guidance using RCA, FMEA, DOE and process improvements.
• Ensure GMP/ISO 13485 and 21 CFR 820 compliance; support audits.
• Lead change control and continuous improvement initiatives.

Skills

Statistical analysis

Root cause analysis

Quality engineering

Minitab

Regulatory knowledge

Education

BS in Engineering

Tools

Minitab

MS Word

Excel

MS Project

Job description

embecta, a global medical device company, is seeking a Site Validation Engineer in Nebraska to execute validation initiatives supporting product design and maintain the validation program. You will collaborate with Quality Systems and Quality Engineering to uphold rigorous standards and drive improvements.

The role requires a BS in Engineering and 3+ years of quality/validation experience, with strong RCA, DOE, and regulatory knowledge.