Project Manager - Quality Remediation Programs

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 the diversified manufacturing partner of choice that helps market-leading brands design, build and deliver innovative products that improve the world. A career at Flex offers the opportunity to make a difference and invest in your growth in a respectful, inclusive, and collaborative environment. If you are excited about a role but don't meet every bullet point, we encourage you to apply and join us to create the extraordinary.

Position Summary

The Project Manager – Quality Remediation Programs is responsible for leading complex, cross‑functional remediation initiatives to address quality system gaps, regulatory findings, and operational risks. This role drives execution of corrective and preventive actions (CAPA), ensures compliance with applicable standards (e.g., ISO 13485, FDA, GMP), and restores sustainable quality system performance. The role requires strong program governance, stakeholder alignment, and the ability to operate under high‑pressure, high‑visibility conditions (e.g., audit observations, warning letters, or compliance commitments).

Key Responsibilities

Remediation Program Leadership

• Lead end‑to‑end execution of quality remediation programs, including scope definition, planning, execution, and closure
• Establish and manage integrated project plans covering CAPA, nonconformance remediation, process improvements, and documentation updates
• Ensure alignment with regulatory commitments, audit responses, and compliance timelines

Quality System Improvement

• Partner with Quality and Operations teams to identify systemic gaps and drive sustainable fixes
• Oversee development and implementation of CAPA plans, ensuring effectiveness checks and closure rigor
• Drive standardization and improvement of quality processes (e.g., DHF/DMR, change control, risk management, TMV)

Governance & Reporting

• Establish robust governance structure including executive reviews, program dashboards, and escalation pathways
• Track and report remediation progress, risks, and key performance indicators (KPIs) to senior leadership
• Ensure documentation readiness for audits and regulatory inspections

Cross‑Functional Coordination

• Coordinate activities across Engineering, Operations, Quality, Supply Chain
• Remove barriers and resolve conflicts to maintain program timelines
• Align internal teams and external partners on deliverables and expectations

Risk Management

• Identify, assess, and proactively mitigate risks impacting remediation timelines or compliance outcomes
• Ensure traceability between issues, root causes, corrective actions, and verification activities

Audit & Inspection Readiness

• Support internal and external audits, including preparation, response coordination, and closure of findings
• Ensure remediation deliverables meet regulatory expectations for completeness, clarity, and traceability

Required Qualifications

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

Preferred Qualifications

• PMP or equivalent project management certification
• Experience supporting regulatory inspections (FDA, notified bodies, customers)
• Background in quality engineering, regulatory affairs, or manufacturing operations
• Familiarity with digital quality systems (eQMS platforms)

Key Competencies

• Execution under pressure – Ability to deliver in time‑sensitive, high‑stakes remediation environments
• Structured problem solving – Strong root cause analysis and data‑driven decision making
• Stakeholder influence – Effective communication at all organizational levels, including executives
• Attention to detail & compliance mindset – Ensures rigor, traceability, and audit readiness
• Program governance excellence – Drives accountability and transparency across complex initiatives

Success Metrics

• On‑time closure of CAPAs and remediation milestones
• Reduction in repeat findings / audit observations
• Improved quality system performance metrics
• Audit/inspection outcomes (no major observations tied to remediated areas)
• Stakeholder alignment and program predictability

Environment & Scope

• Works in a global, cross‑functional environment
• High visibility with senior leadership

MF15

Flex is an Equal Opportunity Employer and employment selection decisions are based on merit, qualifications, and abilities. We do not discriminate based on: age, race, religion, color, sex, national origin, marital status, sexual orientation, gender identity, veteran status, disability, pregnancy status, or any other status protected by law. We're happy to provide reasonable accommodations to those with a disability for assistance in the application process. Please email [e-mail] and we'll discuss your specific situation and next steps (NOTE: this email does not accept or consider resumes or applications. This is only for disability assistance. To be considered for a position at Flex, you must complete the application process first).