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Lead and Manage the Validation Team: Oversee daily operations, allocate work, and ensure high performance and quality output.
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Drive Validation Projects: Serve as the lead on all validation projects, ensuring alignment with protocols and production requirements.
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Ensure Compliance: Develop strategies to meet regulatory requirements, maintain validation policies and procedures, and manage the Validation Master Plan.
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Lifecycle Management: Oversee product and process transfers, manage PFMEA and control plans, and support post-validation activities.
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Technical Execution: Lead IQ, OQ, PQ, and process development activities, including DOE and MSA, to ensure process effectiveness.
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Cross-Functional Collaboration: Work closely with Operations, Planning, and Engineering teams to validate manufacturing processes.
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Regulatory Audits: Participate in regulatory audits and ensure all validation activities meet industry standards.
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Minimum 5 years of high-volume engineering experience in the medical device industry
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3 + years of experience in validation processes
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BA/BS Engineering or related technical qualification
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Proficient in statistical techniques, including Minitab, Six Sigma (preferably Green Belt), and Sampling Plans/Sizes.
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Strong experience in process development, DOE, and risk management (FMEA).
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Excellent documentation skills and a strong understanding of process validation.
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Proven ability to lead a team, manage projects, and communicate effectively across departments
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Strong problem-solving skills and the ability to work independently or as part of a team.