Quality Remediation Project Manager

2 weeks ago

Newark, DE, United States Integrated Resources Full time
Job Title: Quality Remediation Project Manager
Job Location: Newark / Remote, DE
Job Duration: 12 Months (possibility of extension)
Job Summary:
  • 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 company's 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.
Preferred Minimum Non-Technical Degree:
  • College Degree.
Preferred Minimum Technical/Advanced Degree:
  • Technical Bachelor's Degree.
Experience:
  • 5-8 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.
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%.

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