On-site Validation Engineer – Medical Devices (IQ/OQ/PQ)

Medix™; Milwaukee (WI); Presencial; USD 80 000 - 120 000; Tempo integral

Resumo da oferta

Medix, a growing medical device manufacturer in the Milwaukee area, seeks a Validation Engineer to lead IQ/OQ/PQ activities and manage validation master plans. You will collaborate with R&D, Manufacturing, Quality and Regulatory teams to ensure compliant validation deliverables and drive production improvements.

The role requires 2–4 years of validation experience in medical devices, strong documentation skills, and a Bachelor’s (preferred) or Associate degree.

Qualificações

• Experience executing IQ, OQ, PQ protocols and generating corresponding documents.
• Ability to manage Validation Master Plans, SOPs, Protocols, Work Instructions, and risk analyses.
• Familiarity with FDA 21 CFR Part 820 and ISO 13485 compliance requirements.

Responsabilidades

• Develop and execute IQ, OQ, and PQ protocols for equipment, processes, utilities, analytical methods, and software.
• Author, review, and manage Validation Master Plans, SOPs, Protocols, Work Instructions, and risk analyses (FMEAs).
• Ensure validation practices and documentation comply with FDA 21 CFR Part 820 and ISO 13485 standards.
• Interface with R&D during design transfer and support DOE and statistical analysis.
• Support production validation and qualifications of sterilization processes.
• Monitor validation KPIs and communicate status to teams and customers.

Conhecimentos

IQ/OQ/PQ execution

Regulatory documentation

Validation master plans

Regulatory compliance

Formação académica

Associate degree

Bachelor's degree preferred

Ferramentas

FMEA

DOE

SPC

Descrição da oferta de emprego

Medix, a growing medical device manufacturer in the Milwaukee area, seeks a Validation Engineer to lead IQ/OQ/PQ activities and manage validation master plans. You will collaborate with R&D, Manufacturing, Quality and Regulatory teams to ensure compliant validation deliverables and drive production improvements.

The role requires 2–4 years of validation experience in medical devices, strong documentation skills, and a Bachelor’s (preferred) or Associate degree.