Quality and Validation Engineers

Role: Quality & Validation Engineers

Location: Waukegan, IL

Employment Type: Contract / Consulting

Medline Industries is seeking experienced Quality and Validation Engineers to support a large-scale FDA remediation and quality compliance initiative within the medical device industry.

We are looking for professionals with hands-on experience in quality systems, validation, regulatory compliance, and remediation activities.

Key Specializations:

1. Process Validation Engineers

• IQ/OQ/PQ protocols and execution
• Process validation, revalidation, and manufacturing process qualification
• FDA 21 CFR Part 820 and ISO 13485

2. Sterilization Validation Engineers

• Medical device sterilization validation and requalification
• Experience with EO, gamma irradiation, or other sterilization methods
• Knowledge of ISO 11135 and ISO 11137

3. Quality Engineers – CAPA & Remediation

• Root Cause Analysis (RCA), CAPA investigations, and effectiveness checks
• Nonconformance management and quality system improvements
• FDA audit observations and remediation documentation

4. Computer System Validation (CSV) Engineers

• GxP computerized system validation
• Validation protocols, risk assessments, and testing
• 21 CFR Part 11 and regulatory compliance

Required Qualifications:

• Bachelor's degree in Engineering, Life Sciences, or a related technical field.
• Strong medical device or regulated healthcare manufacturing experience.
• Hands-on expertise in at least one of the specializations listed above.
• Knowledge of FDA regulations, QMSR, and ISO 13485 requirements.
• Strong technical documentation, investigation, and problem-solving skills.
• Experience with FDA remediation, warning letter responses, or quality system improvement projects is highly preferred.

Key Responsibilities:

• Address FDA-related quality system gaps and compliance deficiencies.
• Review and update procedures, validation protocols, reports, and quality records.
• Develop and execute remediation plans and corrective actions.
• Collaborate with Quality, Regulatory Affairs, Manufacturing, and Engineering teams.
• Support inspection readiness and sustainable quality improvements.