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This is where your creativity addresses challenges! As QA Engineering Lead you provide Quality Assurance leadership and oversight for engineering-related quality processes across medical device, solutions, and pharmaceutical manufacturing sites. This role ensures that validation, change control, metrology, utilities/facilities, and operational excellence activities are executed in compliance with applicable medical device, pharmaceutical, and combination-product regulations and standards, while enabling efficient, reliable, and scalable operations. The role partners closely with Engineering, Manufacturing, Operations, IT, Regulatory Affairs, and Quality teams to ensure that technical changes, systems, and infrastructure remain compliant, well controlled, and aligned with business objectives and patient safety requirements across regulated environments.
Job Responsibility
Provide QA oversight and governance for validation, change control, and lifecycle management of equipment, processes, utilities, facilities, and computerized systems across medical device and pharmaceutical operations, ensuring compliance with global regulatory standards (FDA, ISO, EU GMP, ICH, GAMP)
Review and approve validation, qualification, calibration, and change control documentation, ensuring systems remain in a state of control and risks to product quality, patient safety, and compliance are effectively managed
Support new product introductions, technology transfers, automation, digital solutions, and facility expansions, partnering with Engineering and Operations to embed Quality principles into continuous improvement initiatives
Oversee critical utilities, facilities, and metrology programs, ensuring systems are qualified, maintained, monitored, and inspection-ready, with appropriate mitigation of deviations and out-of-tolerance conditions
Act as a key Quality partner during audits and inspections, drive standardization and simplification of QA Engineering processes, provide coaching and guidance to technical teams, and influence quality outcomes in a matrixed environment
Requirements
Bachelor's degree in Engineering or similar
7+ years of experience in Quality, Engineering, Validation, or Manufacturing within regulated medical device and/or pharmaceutical environments
Strong working knowledge of validation/CSV, change control, utilities and facilities qualification, and quality systems
Experience supporting regulatory inspections and audits
Nice to have
Experience with FDA QMSR / 21 CFR 820, ISO 13485, 21 CFR 210/211, EU GMP, ICH Q7, and GAMP 5
Experience supporting combination products or multi-platform manufacturing sites
Familiarity with lean, continuous improvement, or business excellence systems in regulated environments