Engineering Project Manager – Medical Devices
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(QA Engineering Project Manager)
Location: North Chicago, IL (Hybrid – Tuesday, Wednesday & Thursday onsite)
Travel: Approximately 10–15% travel to Costa Rica if needed
Duration: 1-Year Contract
Pay Rate: $60-$64/hr based on benefit selection
Orion Group is seeking an experienced Engineering Project Manager – Medical Devices to support a global pharmaceutical and medical device organization. This position will lead complex quality engineering initiatives supporting global product transfers, manufacturing expansion, and new production line implementation. The successful candidate will provide technical leadership while remaining hands-on in driving quality, validation, compliance, and engineering activities across cross-functional teams.
This role is ideal for an experienced engineering professional with a background in medical device manufacturing who has successfully managed global product transfers and enjoys collaborating with engineering, manufacturing, quality, and regulatory partners in a highly regulated environment.
Key Responsibilities
- Lead quality engineering activities supporting global product transfers, manufacturing expansions, and new production line implementations.
- Provide technical leadership for quality engineering activities involving manufacturing processes, equipment, utilities, facilities, and validation programs.
- Partner with Engineering, Manufacturing, Validation, Regulatory Affairs, Quality Systems, and Development teams to ensure successful execution of projects.
- Develop and execute validation and qualification strategies while ensuring compliance with cGMP, regulatory requirements, and AbbVie Quality Systems.
- Lead quality oversight for process validation, equipment qualification, cleaning validation, utilities, computerized systems, and manufacturing processes.
- Drive risk assessments, quality investigations, compliance initiatives, and implementation of corrective and preventive actions.
- Review manufacturing processes and quality systems to identify compliance gaps and implement risk-based solutions.
- Support change controls, product transfers, and process improvements while maintaining product quality and regulatory compliance.
- Communicate project status, quality metrics, risks, and recommendations to leadership and executive stakeholders.
- Manage project priorities, functional resources, and budgets to support successful project execution.
- Bachelor's or Master's degree in Engineering or a related scientific discipline (Engineering strongly preferred).
- Certified Project Manager (CPM) certification highly preferred.
- Demonstrated experience leading global product
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Lake Bluff, Illinois, United States Orion Group Full-timeEngineering Project Manager – Medical DevicesFind out exactly what skills, experience, and qualifications you will need to succeed in this role before applying below.(QA Engineering Project Manager)Location: North Chicago, IL (Hybrid – Tuesday, Wednesday & Thursday onsite)Travel: Approximately 10–15% travel to Costa Rica if needed Duration: 1-Year...
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