Quality Engineer / Project Lead

Quality Engineer / Project Lead (Customer-Facing) Do you have the skills to fill this role Read the complete details below, and make your application today.

Location: Wallingford, CT

Schedule Monday - Friday 8:00 AM – 5:00 PM or 7:00 AM -4:00 PM

Reports To: Quality Manager (dotted line to Executive Leadership)

Compensation 100,00 - 120,000 Annual

Position Overview

This hybrid role combines Quality Engineering leadership with project management ownership to ensure the successful launch and ongoing production of high-quality, compliant products.

The position serves as a key liaison between the organization and its customers, driving quality execution, managing project timelines, and ensuring alignment between customer requirements and internal manufacturing processes.

The ideal candidate brings a strong quality engineering foundation, the ability to lead cross-functional projects, and the confidence to represent the organization in technical, customer-facing discussions.

Key Responsibilities

Quality Engineering (Primary Focus)

Lead quality planning and execution for new and existing products, with emphasis on regulated environments (ISO 13485 preferred)

Develop and maintain quality documentation including:

Control Plans

PFMEA / Process Flow Diagrams

Validation protocols (IQ/OQ/PQ)

Inspection plans and test methods

Drive root cause investigations (NCRs, CAPAs, complaints) using structured problem-solving methodologies

Perform and analyze:

Gage R&R / MSA

Capability studies

Statistical analysis using tools such as Minitab/SPC

Ensure compliance with customer, regulatory, and internal QMS requirements

Support and participate in internal and external audits

Partner with manufacturing to drive continuous improvement and defect reduction

Project Leadership / Customer Interface

Act as the primary point of contact for customers on quality and project-related matters

Lead cross-functional teams to ensure on-time, on-spec product launches

Translate customer technical and quality requirements into actionable internal plans

Track and communicate project timelines, risks, and milestones to leadership

Coordinate across:

Manufacturing

Engineering

Sales

Suppliers

Provide clear, confident communication in customer meetings and technical discussions

Support production ramp-up and resolve issues impacting delivery, cost, or quality

Manufacturing & Process Oversight

Evaluate and improve manufacturing processes for efficiency, quality, and cost-effectiveness

Collaborate with production teams to ensure process control and repeatability

Support PPAP/FAI activities as required

Drive lean and continuous improvement initiatives

Qualifications

Required

5–7 years of experience in Quality Engineering within manufacturing

Experience working in regulated environments (medical device preferred)

Proven ability to interface directly with customers and represent quality function

Hands-on experience with:

Root cause analysis / CAPA

Statistical tools (Minitab, SPC)

Blueprint reading and GD&T

Working knowledge of:

ISO 9001 and/or ISO 13485

Validation (IQ/OQ/PQ)

PPAP elements

Ability to lead projects and influence cross-functional teams

Preferred

Experience working with large OEM customers in regulated industries

ASQ Certification (CQE, CQA, or CQT)

Exposure to multiple quality systems (ISO, AS, IATF)

Calibration and metrology experience

Key Skills & Traits

Strong communication skills with ability to represent the organization externally

Highly organized with ability to manage multiple priorities

Detail-oriented with strong analytical and problem-solving ability

Comfortable in a fast-paced, hands-on manufacturing environment

Self-driven with ability to work independently and cross-functionally

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. xywuqvp

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