Principal Quality Engineer - Contamination Control Strategy

Responsible for leading and managing quality projects throughout the quality organization. Collaborate with cross-functional teams, both internal and external to quality, and serve as a subject matter expert to ensure compliance to applicable regulations and standards;
Support strategic initiatives with the goal of continually improving our global quality system as well as emergency support when unexpected challenges arise that meet your area of expertise;
Plays a vital role in bridging the gap between conceptual design and practical manufacturing, contributing to the efficient and cost-effective production of high-quality products.

• Lead project initiatives throughout the quality organization by collaborating with cross-functional teams. Present project deliverables to the lead team as well as communicate/train affected groups on procedural or process changes.
• Identify, lead and drive opportunities to improve the Quality Management System through increased efficiency or more robust compliance to applicable regulations.
• Leverages their understanding of the QMS to lead root cause activities as well as planning the corrective or preventative actions for critical quality concerns. Ensure actions are completed in a timely fashion with appropriate resources and supporting evidence is properly documented.
• Evaluate Cost of Quality metrics to identify cost savings opportunities. Propose projects to the lead team and execute on the implementation of approved projects.
• Manage and provide process guidance for manufacturing or corporate functions, ensuring process management is consistently applied across all corporate divisions, manufacturing sites and groups.
• Proficiency in identifying, assessing, and managing risks associated with product and/or process development projects. Apply industry-standard risk management tools and techniques (e.g., FMEA, fault tree analysis) to identify and mitigate potential risks. Complete necessary documentation related to risk management activities, including risk assessment, risk mitigation strategies, and risk control implementation.
• Make significant contributions to Medline’s Global Contamination Control Strategy (CCS) and drive continuous improvement across the pharmaceutical network.
• Develop and implement best practices related to environmental monitoring, particulate control, gowning, cleaning, cleanroom operations, and critical utility systems.
• Provide training and technical leadership to personnel at all organizational levels, from shop floor personnel to executive leadership.
• Lead and support investigations associated with contamination control issues, excursions, and product quality events.
• Serve as a subject matter expert during audits, inspections, and remediation efforts.

• Bachelor’s degree in mechanical engineering, biomedical engineering, electrical engineering, software engineering, or related science.

• None

• At least 7 years of experience in pharmaceutical manufacturing Some medical device engineering and/or quality assurance experience preferred

• Position requires travel up to 30% of the time for business purposes (domestic and international).
• Demonstrated leadership abilities, including:
• Lead project teams by providing structure and delegating tasks in accordance with the skills of each team member
• Promote an engaging atmosphere within the group that helps foster open dialogue and is inclusive to all
• Independently manage projects to ensure deadlines are met and any delays are communicated/mitigated proactively
• Demonstrated Critical Thinking and Problem Solving abilities, including:
• Collaborating with…