Principal Quality Engineer - Contamination Control Strategy

Medline; Northfield Township (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Medline is seeking a seasoned quality professional to lead and manage quality projects across the quality organization. You will collaborate with cross-functional teams and serve as a subject matter expert to ensure compliance with applicable regulations and standards.

You will support strategic initiatives toward a global quality system, provide training and technical leadership, and bridge conceptual design with practical manufacturing for cost-effective, high‑quality production.

Qualifications

• Bachelor's degree in engineering or related science.
• 7+ years in pharmaceutical manufacturing; medical device QA experience preferred.
• Willing to travel up to 30% for business purposes (domestic and international).

Responsibilities

• Lead quality improvement projects across the quality organization with cross-functional teams.
• Drive improvements to the Quality Management System for efficiency and compliance.
• Lead root cause analyses and coordinate corrective/preventive actions with proper documentation.
• Evaluate Cost of Quality metrics and propose savings opportunities.
• Provide process guidance across manufacturing and corporate functions to ensure standardized practices.
• Lead investigations on contamination control issues and product quality events.

Skills

Quality management

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Risk management

Education

Bachelor's degree in mechanical engineering

Biomedical engineering

Electrical engineering

Software engineering

Related science

Job description

Job Summary

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.

Job Description

MAJOR RESPONSIBILITIES:

• 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.

MINIMUM JOB REQUIREMENTS:

Education:

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

Certification / Licensure:

None

Work Experience:

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

Knowledge / Skills / Abilities:

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 cross-functional teams and internal customers as a key contributor and/or project manager, driving solutions and producing results for major projects such as QMS Improvements, Cost Savings opportunities, Process alignments, software launches/improvements; ensuring inputs and stakeholder needs are met
• Managing and engaging on multiple projects with competing needs and resource requirements
• Change management and leadership experience associated with process and QMS enhancements
• Improving organizational efficiencies by solving challenging and ambiguous problems with system and process solutions
• Sound judgment, ability to quickly evaluate information to make decisions while mitigating risk to the business. Capable of maintaining a sense of calm during crisis management to identify and present unique solutions.
• Exposure to statistical techniques and data collection methods to aid decision making based on data
• Good understanding of auditor expectations, able to properly document actions taken and support them through objective evidence. Able to identify compliance gaps and set forth actions to correct deficient areas.

Demonstrated Communication and Interpersonal abilities, including:

• Communicating project status and co