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