About this role
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 LeadershipLead end-to-end execution of quality remediation programs, including scope definition, planning, execution, and closureEstablish and manage integrated project plans covering CAPA, nonconformance remediation, process improvements, and documentation updatesEnsure alignment with regulatory commitments, audit responses, and compliance timelinesQuality System ImprovementPartner with Quality and Operations teams to identify systemic gaps and drive sustainable fixesOversee development and implementation of CAPA plans, ensuring effectiveness checks and closure rigorDrive standardization and improvement of quality processes (e.g., DHF/DMR, change control, risk management, TMV)Governance & ReportingEstablish robust governance structure including executive reviews, program dashboards, and escalation pathwaysTrack and report remediation progress, risks, and key performance indicators (KPIs) to senior leadershipEnsure documentation readiness for audits and regulatory inspectionsCross-Functional CoordinationCoordinate activities across Engineering, Operations, Quality, Supply ChainRemove barriers and resolve conflicts to maintain program timelinesAlign internal teams and external partners on deliverables and expectationsRisk ManagementIdentify, assess, and proactively mitigate risks impacting remediation timelines or compliance outcomesEnsure traceability between issues, root causes, corrective actions, and verification activitiesAudit & Inspection ReadinessSupport internal and external audits, including preparation, response coordination, and closure of findingsEnsure remediation deliverables meet regulatory expectations for completeness, clarity, and traceabilityRequired QualificationsBachelor's degree in Engineering, Quality, Life Sciences, or related field7+ years of experience in project/program management within a regulated industry (medical device, pharma, aerospace, etc.)Proven experience leading quality remediation or compliance transformation programsStrong knowledge of quality systems (e.g., CAPA, ISO 13485, FDA QSR, GMP)Demonstrated ability to manage cross-functional teams in high-pressure environmentsPreferred QualificationsPMP or equivalent project management certificationExperience supporting regulatory inspections (FDA, notified bodies, customers)Background in quality engineering, regulatory affairs, or manufacturing operationsFamiliarity with digital quality systems (eQMS platforms)Key CompetenciesExecution under pressure - Ability to deliver in time-sensitive, high-stakes remediation environmentsStructured problem solving - Strong root cause analysis and data-driven decision makingStakeholder influence - Effective communication at all organizational levels, including executivesAttention to detail & compliance mindset - Ensures rigor, traceability, and audit readinessProgram governance excellence - Drives accountability and transparency across complex initiativesSuccess MetricsOn-time closure of CAPAs and remediation milestonesReduction in repeat findings / audit observationsImproved quality system performance metricsAudit/inspection outcomes (no major observations tied to remediated areas)Stakeholder alignment and program predictabilityEnvironment & ScopeWorks in a global, cross-functional environmentHigh visibility with senior leadershipMF15
What you'll receive for the great work you provide:Full range of medical, dental, and vision plansLife InsuranceShort-term and Long-term DisabilityMatching 401(k) ContributionsVacation and Paid Sick TimeTuition ReimbursementApplication 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] 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).