Quality Assurance Engineer

Quality Engineer / Project Lead (Customer-Facing)

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)

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.

• 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
• 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
• Provide clear, confident communication in customer meetings and technical discussions
• Support production ramp-up and resolve issues impacting delivery, cost, or quality

• 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

• 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

• 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
• 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

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.