Senior Quality Remediation Program Manager

Flex; Buffalo Grove (IL); On-site; USD 110,000 - 160,000; Full time

Job summary

Flex is seeking a Project Manager – Quality Remediation Programs to lead cross‑functional remediation initiatives addressing quality gaps, regulatory findings, and operational risks. You will drive CAPA execution, ensure ISO 13485/FDA GMP alignment, and manage governance in a high‑visibility setting.

Key success includes on‑time CAPA closures, audit readiness, and strong cross‑functional collaboration with Engineering, Operations, and Quality teams in a global environment.

Qualifications

• Bachelor’s degree in Engineering, Quality, Life Sciences, or related field.
• 7+ years of experience in project/program management within a regulated industry.
• Proven experience leading quality remediation or compliance transformation programs.
• Strong knowledge of quality systems (CAPA, ISO 13485, FDA QSR, GMP).
• Demonstrated ability to manage cross-functional teams in high-pressure environments.

Responsibilities

• Lead end-to-end remediation programs from scope through closure.
• Develop integrated plans for CAPA, nonconformance remediation, and docs.
• Ensure alignment with regulatory commitments and timelines.
• Partner with Quality and Operations to identify systemic gaps and fixes.
• Oversee CAPA plans with effectiveness checks and closures.
• Prepare governance dashboards and report KPIs to leadership.
• Support audit readiness and responses for inspections.

Skills

Project management

Quality remediation

CAPA

Regulatory compliance

Cross-functional leadership

Risk management

Stakeholder influence

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, or related field

Tools

eQMS

Job description

Flex is seeking a Project Manager – Quality Remediation Programs to lead cross‑functional remediation initiatives addressing quality gaps, regulatory findings, and operational risks. You will drive CAPA execution, ensure ISO 13485/FDA GMP alignment, and manage governance in a high‑visibility setting.

Key success includes on‑time CAPA closures, audit readiness, and strong cross‑functional collaboration with Engineering, Operations, and Quality teams in a global environment.