Position Title: Manufacturing Quality Remediation Project Manager

Work Location: 600 Technology Drive, Newark, DE 19702, USA

Assignment Duration: 12 Months

Work Arrangement: Onsite

Position Summary: The Project Manager, Manufacturing Quality Remediation, is responsible for leading one or more critical workstreams within our organization's remediation program, specific to manufacturing support. 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.

Key Responsibilities:
• Model all quality values and supports others on our organization's quality system requirements and standards to elevate team's ability to produce high-quality products and implement best practices that emphasize defect prevention, reduction in variation and waste and provide for continuous improvement.
• Responsible for the coordination of assigned Quality efforts and provides support for our organization's global supply chain department as directed by the Manufacturing Quality Director.
• Lead planning and execution of manufacturing remediation workstreams, establish objectives, deliverables, success criteria, and project schedules
• Assist in managing a team of remediation Quality Engineers that identify gaps within manufacturing processes and implement corrections, corrective actions, and process improvements.
• 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 • 8+ years of experience in project or program management in a regulated medical device environment or engineering experience supporting manufacturing.
• Demonstrated experience leading projects involving FDA 21 CFR 820 and ISO 13485 compliance, including manufacturing, CAPA, or QMS remediation.
• Experience with manufacturing, 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 collaboration and interpersonal skills. Adapts communication style to suit different audiences. Creates precise, accurate technical documentation. Able to facilitate group discussions.
• Ability to lead and motivate a high performing project team and supervise execution of projects, keep to timelines and prioritize resources.
• Comprehensive knowledge of manufacturing, investigation, and quality improvement methodologies such as GMP, GDP CIMS, Lean, Root Cause and Root Cause Failure Analysis, TQM, SPC and Six Sigma
• Ability to simultaneously manage multiple large-scale projects in various lifecycle stages.
• 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.

Working Conditions & Physical Demands (If Applicable):
• 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.
• Safety Shoes with Impact and Compression Protection Must be worn in designated areas.

 
 
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: $ 57.36/hr.