Quality Engineer Project Manager
Location: Wallingford, CT Onsite
Schedule: Monday – Friday | 8:00 AM – 5:00 PM or 7:00 AM- 4:00PM
Compensation: $75,000 – $120,000+ (depending on experience)
Employment Type: Direct Hire
Overview
We are seeking a Project Manager to lead customer programs within a precision medical device manufacturing environment, supporting highly regulated, large OEM programs. This individual will be responsible for driving projects from initial quotation through full production launch, ensuring alignment on scope, schedule, cost, and quality.
This is a high-impact role with direct visibility to leadership, ideal for someone who thrives in a fast-paced manufacturing environment and has experience managing New Product Introduction (NPI), tooling, and validation efforts.
Key Responsibilities
Program & Customer Management
- Serve as the primary point of contact for assigned customer programs
- Manage project timelines, milestones, and deliverables
- Lead customer communication including DFM feedback, risk mitigation, and issue resolution
- Coordinate engineering changes (ECOs, PCNs) and ensure alignment across stakeholders
Project Execution
- Lead full project lifecycle: RFQ → Design → Tooling → Validation → Production
- Develop and manage project schedules, budgets, and resource plans
- Drive accountability across Engineering, Tooling, Quality, and Operations
Engineering & Manufacturing Coordination
- Partner with engineering and toolroom teams on design reviews and builds
- Support prototype, pilot, and production readiness
- Ensure manufacturability, scalability, and repeatability of processes
Quality & Regulatory Compliance
- Operate within ISO 13485 and FDA regulated environment
- Coordinate First Article Inspections (FAI), Process Validation (IQ/OQ/PQ), and PPAP-style documentation and submission packages
- Ensure all project documentation is accurate and audit-ready
Risk Management & Problem Solving
- Identify risks related to schedule, tooling, materials, and process capability
- Lead root cause analysis and corrective actions
- Escalate issues and drive recovery plans as needed
Continuous Improvement
- Capture lessons learned and improve execution across programs
- Support Lean initiatives and operational improvements
Qualifications
Required
- 5–7+ years of Project Management experience in medical device manufacturing or precision manufacturing (machining, stamping, tooling environments)
- Experience supporting large OEM medical device customers
- Strong background in quality, engineering, or manufacturing environments
- Experience with NPI, tooling and production launches, and inspection/validation documentation
- Strong understanding of regulated quality systems and change control
Preferred
Experience with progressive stamping, CNC machining, Swiss machining, or EDM
Hands-on experience with PPAPs, validation packages, and inspection processes
PMP or formal project management training
What Success Looks Like
Projects delivered on time and within scope
Successful product launches with minimal post-launch issues
Strong customer communication and satisfaction
Accurate planning and execution of timelines and deliverables
Complete, compliant documentation and audit readiness
Why This Opportunity
Direct exposure to company leadership
High-impact role with ownership of critical customer programs
Opportunity to work on complex, regulated medical device projects
Stable and growing precision manufacturing environment
Company Overview
Top Prospect Group partners with leading organizations to deliver high-quality talent across engineering, manufacturing, and professional services. Since 2010, we have built long-standing relationships by focusing on hard-to-fill roles and delivering results. In 2023, we joined HW Staffing Solutions, expanding our capabilities nationwide.
Apply today or reach out directly to learn more about this opportunity.
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