Principal Engineer Quality

About the Role

Act as the site Subject Matter Expert (SME) for validation of equipment, sterile packaging, mixing, water systems (PW/WFI, distribution loops), filling systems (aseptic and non-aseptic), cleaning processes (CIP/COP, manual cleaning validation), and injection molding processes.

Responsibilities

• Define critical process parameters (CPPs) and critical quality attributes (CQAs) for complex manufacturing processes using risk-based approaches.
• Draft, review, approve, and finalize IQ, OQ, PQ protocols and validation reports for medical device production equipment, testing equipment, and facility utilities.
• Lead and oversee on-site validation execution, verify test data integrity, accuracy, and traceability.
• Draft, review, and optimize validation SOPs, validation master plans, and related validation databases.
• Manage validation deviations, non-conformances, and change controls; drive corrective actions and closure.
• Support internal/external audits, customer audits, and regulatory inspections with complete validation documentation.
• Conduct technical communication and coordination with engineering, production, R&D, and cross-functional teams on validation matters.
• Ensure all validation activities comply with ISO 13485, FDA QSR 21 CFR 820, MDR, and local medical device GMP requirements.
• Travel to both Medline facilities and vendor sites approximately 30% (potential international travel).

Requirements

• Bachelor’s degree or above in Biomedical Engineering, Chemical Engineering, Mechanical Engineering, Quality Management, Pharmaceutical Engineering, or related majors.
• Minimum 7+ years of working experience in the medical device industry with solid IQ/OQ/PQ validation experience.
• Familiar with ISO 13485, medical device GMP, FDA 21 CFR 820, and EU MDR regulatory requirements.
• Familiar with statistical technology and application, especially sampling methods.
• Proficient in writing, reviewing, and approving IQ/OQ/PQ protocols and validation reports independently.
• Good understanding of medical device production processes, equipment validation, cleanroom, and utility system qualification.
• Strong English reading and writing ability, able to understand and prepare English validation documents.
• Rigorous, detail-oriented, with good communication, problem-solving, and cross-team coordination skills.

Benefits

• Health insurance, life and disability coverage.
• 401(k) contributions.
• Paid time off.
• For roles where employees work less than 30 hours per week, benefits include 401(k) contributions, access to the Employee Assistance Program, Employee Resource Groups, and the Employee Service Corps.