Job description

The Quality Engineering Project Manager provides leadership, direction, and technical oversight for the Quality Engineering team within Operations. This role leads quality engineers who support manufacturing processes and provide quality engineering expertise for product, process, equipment, utility, and facility-related activities. The position ensures effective implementation of Client Quality Systems and supports validation, qualification, and risk-based compliance decisions across base business and development or market expansion initiatives. The Quality Engineering Project Manager also manages functional resources and budget while maintaining strong quality, compliance, and operational performance. Responsibilities: • Leads and develops a team of quality engineers supporting manufacturing process quality oversight, validation, qualification, and compliance activities. • Provides functional leadership for quality engineering activities across manufacturing processes, equipment, utilities, facilities, and associated systems. • Provides technical direction for quality engineering matters related to base business operations, development, tech transfer, and market expansion projects. • Ensures validation and qualification strategies, protocols, reports, and lifecycle activities are executed in accordance with Client Quality Systems, cGMP requirements, and applicable regulations. • Reviews quality and compliance gaps related to manufacturing processes, equipment, utilities, systems, and change controls, and drives appropriate risk-based actions. • Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to support compliant implementation of new and existing processes. • Guides risk management activities, including assessments, mitigation planning, and application of quality risk management principles. • Oversees or supports qualification and validation activities for equipment, processes, cleaning, utilities, computerized systems, and methods, as applicable. • Ensures quality engineering issues impacting product quality, process robustness, and regulatory compliance are identified, escalated, and resolved. • Communicates quality engineering status, key risks, trends, and recommendations to management and executive stakeholders, and manages functional resources and budget to support efficient execution. Qualifications: • Bachelor’s Degree required. Engineering degree preferred. • 5+ years of experience with Quality Engineering background supporting design transfers. • Medical device or combination product experience. • Hands-on design transfer experience, specifically: Design verification testing (DVT); Design transfer; V&V / protocol review and approvals; Tech transfer activities • Experience with capital equipment transfers and ideally setting up new production lines. • Strong understanding of validation/verification documentation and quality systems. #LI-KH1

Requirements

Must-haves

Responsibilities: • Leads and develops a team of quality engineers supporting manufacturing process quality oversight, validation, qualification, and compliance activities.
Provides functional leadership for quality engineering activities across manufacturing processes, equipment, utilities, facilities, and associated systems.
Provides technical direction for quality engineering matters related to base business operations, development, tech transfer, and market expansion projects.
Ensures validation and qualification strategies, protocols, reports, and lifecycle activities are executed in accordance with Client Quality Systems, cGMP requirements, and applicable regulations.
Reviews quality and compliance gaps related to manufacturing processes, equipment, utilities, systems, and change controls, and drives appropriate risk-based actions.
Partners with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Development to support compliant implementation of new and existing processes.
Guides risk management activities, including assessments, mitigation planning, and application of quality risk management principles.
Oversees or supports qualification and validation activities for equipment, processes, cleaning, utilities, computerized systems, and methods, as applicable.
Ensures quality engineering issues impacting product quality, process robustness, and regulatory compliance are identified, escalated, and resolved.
Communicates quality engineering status, key risks, trends, and recommendations to management and executive stakeholders, and manages functional resources and budget to support efficient execution.
5+ years of experience with Quality Engineering background supporting design transfers.
Medical device or combination product experience.
Hands-on design transfer experience, specifically: Design verification testing (DVT); Design transfer; V&V / protocol review and approvals; Tech transfer activities
Experience with capital equipment transfers and ideally setting up new production lines.
Strong understanding of validation/verification documentation and quality systems.

Nice-to-haves

Qualifications: • Bachelor’s Degree required. Engineering degree preferred.

Application prep

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