Position Title: QUALITY REMEDIATION PROJECT MANAGER
Work Location: newark, de
Assignment Duration: 12 months
Work Arrangement: Remote or Hybrid

Position Summary:
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.

Background & Context:
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.

Key Responsibilities:
• Lead planning and execution of remediation workstreams, establish objectives, deliverables, success criteria, manage project schedules, ensure adherence to Quality PMO governance
• 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
• 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
• Identify risks, barriers, dependencies; develop mitigation strategies; communicate compliance risks; support root cause analysis, risk evaluation, documentation quality
• 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

Qualification & Experience:
• Preferred Minimum Non-Technical Degree: College Degree
• Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree
• 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.
• Prior experience in large-scale cross-functional quality remediation or transformation programs beneficial.
• Strong understanding of FDA QSR, ISO 13485, ISO 14971, and EU MDR.
• Excellent communicator with strong presentation skills, capable of interfacing with senior leaders, consultants, and regulatory stakeholders.
• Proficient in building integrated schedules, risk registers, dashboards, and PMO governance artifacts (Microsoft Project, Smartsheet, Planview, etc.).
• Skilled in root cause analysis methodologies, data-driven decision-making, and structured problem solving.
• Detail oriented, highly organized, and able to manage multiple priorities under urgent timelines.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 50.00/hr.