Project Manager - Quality Remediation Programs

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. Job Summary 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 What you'll receive for the great work you provide: Full range of medical, dental, and vision plans Life Insurance Short-term and Long-term Disability Matching 401(k) Contributions Vacation and Paid Sick Time Tuition Reimbursement Application Deadline: Applications for this job position will be accepted for at least five days following the job posting start date below and continuing until the end date below or until the position is filled. This posting may close sooner due to application volume. Job Posting Start Date 07-15-2026 Job Posting End Date 09-16-2026 The base pay range for this position is provided below. The final base rate offered will be determined using job-related, non-discriminatory criteria, including but not limited to experience, qualifications, geographic location, education, external market data, and internal equity. $89,200.00 USD - $122,700.00 USD Annual Job Category Quality Is Sponsorship Available? No 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 [email protected]