Manufacturing Project Manager

Title:
Quality Remediation Project/Program Manager

Location:
Newark, DE

Duration: 12+ Months

Shift & Timing:
Regular Business Hours

Pay Range: $89.71/Hour

• The Project Manager, Quality Remediation, is responsible for leading one or more critical work streams 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.
• 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.
• Program Leadership & Execution:
  Lead planning and execution of remediation work streams, 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
• 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.

If you are not interested in looking at new opportunities at this time I fully understand. I would in that case be appreciative of any referrals you could provide from your network of friends and colleagues in the industry. We do offer a referral bonus that I’d be happy to extend to you if they turn out to be a great fit for my client.

Thank you for your time and for your consideration. I look forward to hearing from you.