VP, QA Franchise (Med Device)

Location: Hybrid, Allentown, Pennsylvania, United States; Monday–Friday, 5×8 schedule. Occasional business travel required.

Salary: $260,000–$290,000 annually

Company

Medical technology company developing, manufacturing, and marketing infusion therapy, pain management, nutrition, pharmacy compounding, ostomy, wound care, and dialysis products and services for the healthcare industry.

What you will do

• Provide strategic leadership for quality assurance across the medical device franchise and support compliance with global regulations.
• Ensure devices are designed, validated, manufactured, and distributed according to design control, risk management, and corporate quality standards.
• Partner with Business Unit leadership, Regulatory Affairs, Engineering, and R&D throughout product development, manufacturing, and lifecycle management.
• Develop and report quality metrics covering nonconformities, CAPA trends, complaints, audits, field actions, compliance risks, and site performance.
• Coordinate FDA-required and global post-market surveillance, including complaint handling, vigilance reporting, trend analysis, and field corrective actions.
• Manage the franchise quality budget, supplier quality oversight, remediation projects, and communications with regulatory authorities.

Requirements

• Bachelor’s degree required; master’s degree preferred.
• Minimum 10 years of related experience, including at least 7 years in quality management.
• Broad professional and industry knowledge with the ability to develop advanced quality strategies, principles, and processes.
• Experience directing broad functional areas through division heads and allocating organizational resources.
• Ability to resolve complex problems and represent the organization with senior internal and external stakeholders.
• Applicable industry or professional certification preferred.

Nice to have

• Master’s degree.
• Applicable industry or professional certification.

Culture & Benefits

• Healthcare benefits.
• 401(k) plan.
• Tuition reimbursement.
• Focus on sharing expertise, continuous improvement, innovation, efficiency, sustainability, and patient safety.
• Equal opportunity employment environment.