Senior Quality Engineer

Responsibilities

• Lead and mentor a team of Quality Engineers, providing technical guidance, performance management, and career development.
• Oversee quality engineering activities supporting manufacturing, product development, supplier quality, and sustaining engineering efforts.
• Ensure compliance with FDA Quality System Regulations (21 CFR Part 820), ISO 13485, and applicable international regulations.
• Drive investigations related to nonconformances, deviations, complaints, and CAPAs while ensuring timely and effective resolution.
• Lead root cause analysis efforts using structured problem-solving methodologies and implement corrective and preventive actions.
• Review and approve quality documentation, engineering changes, validation protocols, risk assessments, and design control deliverables.
• Oversee process validation activities including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Partner with Manufacturing, Operations, R&D, Regulatory Affairs, and Supply Chain teams to drive quality improvements and operational excellence.
• Support new product introductions, manufacturing transfers, and process improvement initiatives.
• Establish and monitor key quality metrics and drive data-based decision-making across the organization.
• Lead internal audits, supplier audits, and support FDA inspections, ISO audits, and regulatory submissions.
• Ensure effective supplier quality management processes including supplier qualification, performance monitoring, and risk mitigation.
• Champion continuous improvement initiatives utilizing Lean, Six Sigma, and quality engineering best practices.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 7+ years of Quality Engineering experience within the medical device industry.
• 2+ years of leadership, supervisory, or project leadership experience.
• Strong working knowledge of FDA regulations, 21 CFR Part 820, ISO 13485, CAPA systems, risk management, and design controls.
• Experience supporting Class II and/or Class III medical devices.
• Proven experience leading investigations, CAPAs, audits, and validation programs.
• Experience with IQ, OQ, and PQ development, execution, and approval.
• Strong understanding of manufacturing processes, process validation, and quality systems.
• Excellent communication, leadership, and stakeholder management skills.

Preferred Qualifications

• Experience supporting diabetes management, drug delivery, wearable medical devices, or connected health products.
• ASQ Certified Quality Engineer (CQE), Certified Quality Manager (CQM), or equivalent certification.
• Leverage Lean Six Sigma Green Belt or Black Belt certification.
• Experience in a high-growth medical device environment.
• Experience supporting global regulatory inspections and supplier networks.