BEPC Inc. - Business Excellence Professional Consulting · 1 day ago
Project Manager - 29182_C
Newark, DE
Contract
Onsite
Senior Level, Lead/Staff
$57.36/hr - $89.71/hr
8+ years expBEPC Inc. is seeking an experienced Manufacturing Quality Remediation Project Manager to lead critical manufacturing-related workstreams within a large-scale quality remediation program. This role requires strong project management expertise and deep knowledge of medical device manufacturing and Quality Management Systems (QMS).
BiotechnologyConsulting
Responsibilities
Lead planning and execution of manufacturing quality remediation workstreams, including objectives, deliverables, timelines, and success criteria
Provide disciplined project management to ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable global regulations
Coordinate cross-functional activities with Quality, Regulatory, R&D, Operations, Service, IT, and Manufacturing teams
Support and guide a team of Quality Engineers conducting gap assessments on the manufacturing floor
Identify process gaps and lead implementation of corrections, corrective actions, and process improvements
Facilitate working sessions, risk assessments, root cause analyses, and verification planning
Develop and maintain project dashboards, schedules, risk registers, and status reports for leadership
Identify risks, barriers, and dependencies; develop mitigation strategies and communicate compliance risks
Partner with process owners and SMEs to implement sustainable, long-term quality solutions
Recommend enhancements to procedures, templates, training, governance, and system integrations
Promote a strong quality culture focused on defect prevention, variation reduction, and continuous improvement
Qualification
Required
Bachelor's degree (technical degree preferred)
8+ years of experience in project or program management within a regulated medical device or manufacturing environment
Demonstrated experience supporting FDA 21 CFR 820 and ISO 13485 compliance initiatives
Strong background in manufacturing support, quality systems, and risk management
Experience leading or supporting CAPA, remediation, or large-scale quality transformation programs
Proven ability to manage multiple complex workstreams simultaneously
Preferred
Experience leading cross-functional or enterprise-wide remediation programs
Strong knowledge of ISO 14971, EU MDR, and risk-based quality systems
Experience with Lean, Six Sigma, SPC, Root Cause Analysis, and continuous improvement methodologies
Proficiency with project management tools (Microsoft Project, Smartsheet, Planview, or similar)
Experience mentoring or guiding engineers and project team members
Benefits
Dental insurance
Health insurance
Life insurance
Vision insurance
Company
BEPC Inc. - Business Excellence Professional Consulting
BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.
201-500 employees
Funding
Current Stage
Growth StageLeadership Team
Oscar Casillas
President and CEO
Andrew Casillas
Human Resources Partner
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