Quality Engineering Project Manager

Job Summary

We are seeking an experienced Quality Engineering Project Manager to lead quality engineering initiatives supporting manufacturing operations in a large enterprise environment.

Key Responsibilities

• Lead and develop a team of quality engineers supporting manufacturing operations.
• Provide technical leadership for quality engineering activities involving manufacturing processes, equipment, utilities, facilities, and supporting systems.
• Manage validation and qualification strategies, documentation, execution, and lifecycle activities.
• Support global product transfer projects and manufacturing expansion initiatives.
• Partner with manufacturing, engineering, validation, regulatory, development, and quality teams to ensure compliant implementation of new and existing processes.
• Review quality issues, change controls, compliance gaps, and risk assessments while driving appropriate corrective actions.
• Support qualification and validation of equipment, processes, cleaning, utilities, computerized systems, and analytical methods.
• Communicate project status, quality risks, and recommendations to leadership while managing project resources.

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Pharmacy, Physical Sciences, or a related discipline.
• Minimum of 8 years of experience in Manufacturing, Quality Assurance, Quality Control, Research and Development, or Quality Engineering within pharmaceutical, biologics, medical device, or chemical manufacturing.
• Minimum of 4 years of leadership or supervisory experience.
• Hands on experience managing global product transfers within the medical device industry.
• Experience supporting manufacturing and engineering teams with new production line implementation.
• Strong knowledge of validation, qualification, quality systems, regulatory compliance, and cGMP requirements.
• Excellent communication, presentation, and stakeholder management skills.

Paid Time Off

• (paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)

Pay Range

Pay Range: $60 to $65 an hour.

Client Industry

Pharmaceutical

Location

North Chicago, IL - 60064

Job Mode

Hybrid (Tuesday, Wednesday, Thursday Onsite; Travel Required - Approximately 10-15% to Costa Rica)

Duration

12 Months Contract (Possibility of Extension based on business needs and performance)