The role will lead end-to-end Quality Assurance oversight across manufacturing operations, ensuring robust quality systems, timely product disposition, sustainable compliance, contamination control, risk management, and operational excellence. The individual will also work closely with Manufacturing, Supply Chain, Engineering, Regulatory Affairs, EHS, R&D, and other cross-functional teams to support compliant manufacturing operations, strengthen quality culture, and enable business objectives.

What we are looking for:

The ideal candidates will bring strong experience in pharmaceutical and/or medical device manufacturing, with a proven track record in Quality Assurance, Manufacturing Quality, cGMP Compliance, Regulatory Inspections, Risk Management, CAPA, Deviations, Change Control, Root Cause Investigations, Product Disposition, and Quality Systems.

Key Responsibilities:

• Lead end-to-end Quality Assurance oversight across Vascular manufacturing operations, ensuring manufacturing activities are adequately supported, operationally efficient, and fully compliant with cGMP (21 CFR Parts 210/211), QSR (21 CFR Part 820), ISO 13485, EU GMP, and global quality standards.
• Serve as the site Subject Matter Expert (SME) for Manufacturing Quality, providing strategic oversight of production quality, in-process controls, batch record review, product disposition, contamination control, and risk-based decision making while ensuring manufacturing operations remain inspection-ready.
• Provide strategic oversight of Quality Systems, ensuring effective management of deviations, CAPAs, change controls, complaints, investigations, verification of effectiveness (VoE), and sustainable corrective actions while driving continuous improvement across manufacturing operations.
• Lead Quality Compliance and Regulatory Readiness by ensuring compliance with FDA, EU GMP, ISO 13485, and global quality requirements, acting as the site QA lead during FDA inspections, regulatory audits, customer audits, and regulatory responses.
• Drive Quality Risk Management and Operational Excellence by leveraging data-driven analysis, root cause investigations, quality metrics, trend analysis, and risk management principles to identify systemic issues, strengthen quality systems, and improve manufacturing performance.
• Build and develop a high-performing Quality Assurance organization by providing leadership, coaching, and technical mentorship, fostering a culture of accountability, ownership, urgency, execution, continuous learning, and a strong quality mindset while ensuring appropriate capability across operations and quality systems.
• Drive strategic quality initiatives through effective collaboration with Manufacturing, Supply Chain, Engineering, Regulatory Affairs, EHS, R&D, and cross-functional stakeholders to support business continuity, validated manufacturing processes, supply reliability, and operational excellence.

Candidate Profile:

• 10+ years of relevant experience in Quality Assurance, Pharmaceutical Manufacturing, or Medical Device Manufacturing.
• 5+ years of leadership experience managing Quality teams, manufacturing quality functions, or site-level quality operations.
• Strong knowledge of FDA regulations (21 CFR Parts 210/211/820), EU GMP, ISO 13485, cGMP, Quality Systems, Risk Management, and regulatory inspection requirements.
• Experience supporting regulatory inspections and interactions, including FDA inspections, 483 observations, Warning Letters, customer audits, and regulatory remediation activities.
• Strong ability to lead cross-functional teams, drive accountability, strengthen quality culture, and support operational excellence.
• Pharmaceutical manufacturing experience is strongly preferred.
• Experience with Lean/Six Sigma methodologies, SAP, and enterprise Quality Management Systems is preferred.