Quality Engineering Project Manager

To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL Anwesha Mohapatra, Collabera | LinkedIn), email your updated resume at Email anwesha.mohapatra@collabera.com. Thank you! Pay Range: $50/hr to $55/hrJob Title: Project Manager III, Non ITLocation: North Chicago, Illinois 60085Work Type: HybridContract Duration: 12 Months, with possible extension based on performance and business needs Job Summary:We are seeking an experienced Project Manager III to lead quality engineering initiatives, manufacturing operations support, and global product transfer projects within the pharmaceutical or medical device industry. The ideal candidate will bring strong technical leadership, quality engineering expertise, and experience coordinating cross functional teams across manufacturing, engineering, validation, and regulatory functions. This role oversees validation and qualification strategies, quality compliance, risk management, and operational improvement initiatives. The successful candidate will provide technical direction, manage resources and budgets, and ensure project deliverables meet applicable quality and regulatory requirements. Experience supporting manufacturing and engineering sites during the establishment of new production lines and global product transfers is highly valued. Key Responsibilities:Lead and develop quality engineering teams supporting manufacturing processes, validation, qualification, and regulatory compliance activities.Provide technical leadership for quality engineering initiatives involving manufacturing processes, equipment, utilities, facilities, and associated systems.Manage product transfer, technology transfer, development, and market expansion projects across global manufacturing and engineering sites.Coordinate activities required to establish new production lines, ensuring appropriate quality engineering oversight and operational readiness.Develop and oversee validation and qualification strategies, protocols, reports, and lifecycle activities in accordance with applicable quality systems and cGMP requirements.Evaluate quality and compliance gaps related to manufacturing processes, equipment, utilities, systems, and change controls, and implement appropriate risk based actions.Collaborate with Manufacturing, Validation, Engineering, Regulatory, Quality Systems, and Product Development teams to support compliant implementation of new and existing processes.Lead quality risk management activities, including risk assessments, mitigation planning, and compliance evaluations.Oversee qualification and validation activities for equipment, processes, cleaning procedures, utilities, computerized systems, and analytical methods, as applicable.Identify, escalate, and resolve quality engineering issues affecting product quality, manufacturing performance, process robustness, and regulatory compliance.Communicate project progress, quality risks, performance trends, and recommendations to management and executive stakeholders.Manage functional resources, project priorities, and budgets to support timely execution and effective operational performance. Required Qualifications:Bachelor's degree in Engineering, Physical Sciences, Life Sciences, Pharmacy, or a related scientific discipline.At least eight years of combined experience across Manufacturing, Quality Assurance, Quality Control, or Research and Development within the pharmaceutical, biologics, medical device, or chemical industry.At least four years of supervisory or technical leadership experience.Demonstrated experience leading or directly supporting global product transfers within the medical device industry.Experience working with manufacturing and engineering sites to establish new production lines.Working knowledge of product physical and chemical characteristics, including raw materials and manufactured products.Knowledge of quality systems, cGMP requirements, applicable regulatory standards, and electronic document management systems.Familiarity with statistical quality systems and laboratory information management systems.Strong people management, stakeholder communication, presentation, and cross functional collaboration skills.Ability to exercise sound judgment, manage competing priorities, resolve operational challenges, and work effectively across complex organizational structures. Preferred Qualifications:Master's degree or PhD in Engineering, Life Sciences, or a related scientific discipline.Certified Quality Engineer credential or formal training in quality engineering or statistics.Experience building and sustaining high performing teams responsible for manufacturing operations, compliance remediation, site projects, and global project deliverables.Demonstrated strategic planning, negotiation, and stakeholder influencing skills across complex functional teams.Experience managing project budgets, resource allocation, and quality engineering initiatives across multiple manufacturing locations. Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)