Senior Medical Device Quality & Compliance Lead

AbbVie; Westport; On-site; EUR 97,000 - 185,000; Full time

Job summary

AbbVie is seeking a senior quality assurance leader to oversee the quality and regulatory conformance of combination products and medical devices. The role covers on‑market support, audits, and coordination with contract manufacturers to ensure compliant, timely delivery.

The position requires a strong background in QA, regulatory affairs, and cross‑functional leadership, with a focus on risk management and continuous improvement across global programs.

Qualifications

• Bachelor’s Degree in Life Science or related field
• Graduate degree in a technical field is preferred
• Experience in quality assurance and regulatory environments

Responsibilities

• Ensure delivery of quality elements for on‑market support of combination products and medical devices
• Support Global Product Quality Assurance strategy and implement agreed strategy
• Make key decisions on quality, compliance and regulatory conformance for devices and combination products
• Lead collection, verification and improvement of Quality metrics for management review
• Lead a team of SMEs to achieve on‑time quality deliverables and optimize the organization
• Participate in development of global Product Quality Assurance strategy for devices and contract manufacturers
• Communicate with external quality organizations to balance quality, timelines, and costs
• Interface with audit team to develop plans, readiness, and corrective actions; support inspections
• Lead product quality investigations and corrective actions; follow-up on complaints
• Collaborate with internal/external partners on feedback for management reviews

Skills

Quality assurance

Regulatory compliance

Problem solving

Leadership

Cross-functional collaboration

Education

Bachelor’s Degree in Life Science

Graduate degree desired

Job description

AbbVie is seeking a senior quality assurance leader to oversee the quality and regulatory conformance of combination products and medical devices. The role covers on‑market support, audits, and coordination with contract manufacturers to ensure compliant, timely delivery.

The position requires a strong background in QA, regulatory affairs, and cross‑functional leadership, with a focus on risk management and continuous improvement across global programs.