Quality Engineer, Medical Devices – Root Cause Leader

Integratedcooling; Pelham (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

Pelham Plastics is seeking a hands-on Quality Engineer to ensure medical device quality across the manufacturing lifecycle, from engineering transfers to production floors. You will collaborate with engineering, manufacturing, suppliers, and customers to resolve complex quality issues and lead root cause investigations.

The role emphasizes measurement systems, GD&T, risk management, and ISO 13485/FDA QMSR compliance, with opportunities to influence supplier quality and drive continuous

Qualifications

• Bachelor's degree in engineering or equivalent.
• 5+ years of Quality Engineering experience in medical devices or regulated manufacturing.
• Ability to read blueprints and schematics; strong QC and inspection knowledge.
• Strong writing, communication, and problem-solving skills.

Responsibilities

• Serves as the primary Quality representative for manufacturing on the plant floor.
• Uses measurement and testing tools to evaluate product quality.
• Leads investigations of nonconforming product using root cause analysis.
• Drives supplier quality improvement through SCARs and supplier investigations.
• Interprets drawings and specifications using GD&T principles.
• Participates in internal audits, PFMEA, risk assessments, and validations.
• Authors technical reports, CAPAs, risk assessments, procedures, and customer communications.
• Supports customer audits and quality-related customer interactions, including complaints.
• Manages calibration and measurement system program to ISO 13485 and customer requirements.
• Supports engineering changes and product development to ensure quality and regulatory compliance.
• Maintains compliance with Pelham Plastics QMS policies and FDA QMSR requirements.

Skills

Reading blueprints

GD&T knowledge

Quality Control principles

Root cause analysis

Statistical analysis (Minitab)

Technical writing

Organizational skills

Interpersonal skills

Education

Bachelor's degree in an engineering discipline

Tools

Minitab

Measurement tools

Calibration processes

Job description

Pelham Plastics is seeking a hands-on Quality Engineer to ensure medical device quality across the manufacturing lifecycle, from engineering transfers to production floors. You will collaborate with engineering, manufacturing, suppliers, and customers to resolve complex quality issues and lead root cause investigations.

The role emphasizes measurement systems, GD&T, risk management, and ISO 13485/FDA QMSR compliance, with opportunities to influence supplier quality and drive continuous