Quality Remediation Project Manager

Description - QUALITY REMEDIATION PROJECT MANAGER INTAKE NOTES:
Pay Rate: TBD -Remote or Hybrid
Ideal candidate has strong experience supporting the 483/warning letter work; navigating regulations
Candidates who have a military background, tangible experience with Aerospace or Automotive, and Pharmaceuticals are natural fits for this work
The Project Manager, Quality Remediation, is responsible for leading one or more critical workstreams within the companys FDA 483/Warning Letter remediation program. This individual provides disciplined project management, cross-functional alignment, and rigorous adherence to FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable global regulatory requirements.
The Project Manager at this level is a seasoned, experienced professional with a full understanding of area of specialization; resolves a wide range of issues in creative ways. This individual normally receives little instruction on day-to-day work, general instructions on new assignments. This individual demonstrates good judgment in selecting methods and techniques for obtaining solutions. They will build relationships and networks with senior internal and external personnel in their own area of expertise.
Essential Duties and Responsibilities: The table below outlines the key activities and competencies required for each knowledge category. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Category Key Activities
Program Leadership & Execution: Lead planning and execution of remediation workstreams, establish objectives, deliverables, success criteria, manage project schedules, ensure adherence to Quality PMO governance
Regulatory & Quality System Remediation: Align execution with FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR; close systemic quality gaps in Design Controls, Risk Management, QMS Remediation, Management Controls, CAPA, NCE/Nonconformance, Data Analysis, MDR/Field Actions, Complaints & Investigations; ensure documentation accuracy and audit readiness
Cross-Functional Leadership & Communication: Coordinate with Quality, Regulatory, R&D, Operations, Service, IT; facilitate working sessions, risk assessments, problem-solving, verification planning; deliver status updates, dashboards, presentations; maintain configuration control and traceability Risk Management & Issue Resolution: Identify risks, barriers, dependencies; develop mitigation strategies; communicate compliance risks; support root cause analysis, risk evaluation, documentation quality
Sustainable Quality System Improvements: Partner with process owners and SMEs for long-term solutions; recommend enhancements to procedures, templates, governance, training, system integrations; contribute to continuous improvement and quality accountability
Physical Demands: The physical requirements described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Sit; use hands to finger, handle or feel objects, tools, or controls. Stand; walk; reach with hands and arms; and stoop, kneel, crouch, or crawl. Travel (please specify): up to 25% Qualifications: Education
Preferred Minimum Non-Technical Degree: College Degree
Preferred Minimum Technical/Advanced Degree: Technical Bachelors Degree Experience 58 years of experience in project or program management in a regulated medical device environment.
Demonstrated experience leading projects involving FDA 21 CFR 820 and ISO 13485 compliance, including Design Controls, CAPA, Complaints, MDR, or QMS remediation.
Experience supporting or leading FDA inspection response, Warning Letter remediation, or 483 corrective actions strongly preferred.
Experience with Design Control, Quality Systems, and risk-based process improvements.