Manufacturing Quality Remediation Project Manager - 29182_P

Job Title: Manufacturing Quality Remediation Project Manager
Location: Newark, DE 19702
Employment Type: 12 Month Contract with possibility for extensions, W2 Contract
Pay Rate: $57.36 – $89.71/hour (based on experience)
Work Schedule: 100% On-site

Role Overview

BEPC 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, deep knowledge of medical device manufacturing and Quality Management Systems (QMS), and the ability to drive cross-functional alignment in a highly regulated environment.

The ideal candidate is a seasoned quality or project management professional with hands-on experience supporting manufacturing remediation, CAPA, and compliance initiatives aligned with FDA and ISO standards.

Key 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

Required Qualifications

• 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 Qualifications

• 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

Skills & Competencies

• Excellent communication and stakeholder management skills
• Strong documentation and technical writing capabilities
• Ability to influence without authority and lead in matrixed organizations
• Detail-oriented, highly organized, and capable of managing urgent timelines
• Data-driven decision-making and structured problem-solving skills

Work Environment & Physical Requirements

• On-site manufacturing environment
• Frequent presence on the manufacturing floor
• Must be able to sit, stand, walk, reach, and perform routine physical movements
• Safety shoes required in designated areas

About BEPC

BEPC Inc., founded in 2007, is a 100% employee-owned company providing consulting and staffing solutions across technology, engineering, manufacturing, and project management. We are driven by innovation and a commitment to excellence, fostering a collaborative environment where employees can thrive. Competitive benefits include medical, dental, vision, and life insurance to support personal and professional growth.

Apply Now!

Interested candidates should submit an up-to-date resume highlighting experience with manufacturing support, quality remediation, project management, and regulated environments.

USOPS

Pay: $57.36 - $89.71 per hour

Benefits:

• Dental insurance
• Health insurance
• Life insurance
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• project management a regulated medical device: 8 years (Required)
• FDA 21 CFR 820 and ISO 13485 compliance initiatives: 8 years (Required)
• manufacturing, quality systems, and risk management: 8 years (Required)
• CAPA, remediation, or large-scale quality transformation: 8 years (Required)

Location:

• Newark, DE 19702 (Required)

Ability to Commute:

• Newark, DE 19702 (Required)

Work Location: In person

Salary : $57 - $90