Quality Remediation Project Manager

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%.