Project Manager / Quality Engineer – Medical Device Manufacturing
Location: Wallingford, CT
Schedule: Monday – Friday | 8:00 AM – 5:00 PM
Compensation: $90,000 – $120,000 (depending on experience)
Employment Type: Direct Hire
Reports To: Rick Griffen, President
Overview
We are seeking a hands-on Project Manager with a strong Quality Engineering background to lead customer programs within a precision medical device manufacturing environment. This is a hybrid role responsible for both program execution and quality ownership, supporting highly regulated, large OEM medical device programs.
This individual will drive projects from initial quotation through full production launch, while also owning key aspects of quality planning, validation, inspection strategy, and issue resolution. The ideal candidate thrives in a fast-paced manufacturing environment and is comfortable working cross-functionally on the shop floor to ensure successful outcomes.
Key Responsibilities
Program & Customer Management
Serve as the primary point of contact for assigned customer programs
Manage timelines, milestones, and deliverables from RFQ through production
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
Quality Engineering & Compliance
Develop and maintain quality documentation including control plans, inspection methods, and validation protocols
Define inspection criteria and support receiving, in-process, and final inspection strategies
Coordinate and support:
- First Article Inspections (FAI)
- Process Validation (IQ/OQ/PQ)
- PPAP elements (Control Plans, PFMEA, Process Flow, Capability Studies)
Ensure compliance with ISO 13485 and FDA regulated requirements
Maintain audit-ready documentation and support customer and internal audits
Problem Solving & Continuous Improvement
Lead root cause analysis for quality issues, NCRs, CAPAs, and customer complaints
Drive corrective and preventive actions to resolution
Utilize data and statistical tools (SPC, Minitab) to analyze trends and improve processes
Partner cross-functionally to improve product quality, process capability, and overall QMS
Engineering & Manufacturing Coordination
Partner with engineering and toolroom teams on design reviews, tooling builds, and production readiness
Ensure manufacturability, scalability, and repeatability of processes
Work closely with production teams to support successful product launches and ongoing improvements
Qualifications
Required
5–10+ years of experience in Project Management and/or Quality Engineering within:
- Medical device manufacturing
- Precision manufacturing (machining, stamping, tooling environments)
Experience supporting large OEM medical device customers
Strong background in quality systems, validation, and manufacturing processes
Hands-on experience with: - New Product Introduction (NPI)
- Tooling and production launches
- Inspection and validation documentation
Strong understanding of engineering change control and regulated environments
Preferred
Experience with progressive stamping, CNC machining, Swiss machining, or EDM
Hands-on experience with PPAP, MSA/Gage R&R, and capability studies
ASQ certifications (CQT, CQA, CQE) a plus
PMP or formal project management training
Compliance Requirement
Must be a U.S. Citizen or U.S. Permanent Resident (Green Card holder) due to ITAR regulations
What Success Looks Like
Projects delivered on time and within scope
Successful product launches with minimal quality issues
Strong customer communication and program execution
Improved process capability and product quality
Complete, compliant documentation and audit readiness
Why This Opportunity
Direct exposure to company leadership
High-impact role with ownership of both project execution and quality
Opportunity to work on complex, regulated medical device programs
Hands-on environment where you can make a real impact
Stable and growing precision manufacturing company
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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