Quality Engineer - Medical Device

Pelham Plastics, Inc.•Pelham, NH

1d•$80,000 - $105,000•Onsite

About The Position

The Quality Engineer is a key technical resource responsible for ensuring the quality of medical devices throughout the manufacturing lifecycle. This highly visible position offers the opportunity to work directly with engineering, manufacturing, suppliers, and customers to transition products from engineering to production, solve complex quality issues, lead root cause investigations, and support supplier quality improvement within a regulated medical device manufacturing environment. The successful candidate will be an experienced, hands-on Quality Engineer with demonstrated expertise in measurement systems, GD&T, manufacturing quality, root cause analysis, and risk management.

Requirements

Bachelor's degree in a related engineering discipline or equivalent
5+ years of Quality Engineering experience in medical device or other regulated manufacturing environment.
Understanding of engineering principles, practices, and techniques
Able to read blueprints and schematics
Understanding of Quality Control principles and inspection methods
Process validation
Statistical analysis experience (Minitab preferred)
Analytical and problem-solving capabilities
Excellent technical writing, organizational, communication, and interpersonal skills.
Able to lift up to 20 lbs
Sit, stand, bend and stoop
Good visual acuity and capable of fine motor skills.

Responsibilities

Serves as the primary Quality representative supporting manufacturing operations on the plant floor.
Uses a wide variety of measurement and testing tools and equipment to evaluate product quality.
Leads investigations of nonconforming product using structured root cause analysis methodologies; recommends technically sound, risk-based lot disposition decisions.
Drives supplier quality improvement through SCARs, supplier investigations, and performance monitoring.
Interprets engineering drawings and specifications using GD&T principles.
Participates in internal auditing, PFMEA, risk assessments, process validations, and continuous improvement initiatives.
Authors technical reports, CAPAs, risk assessments, procedures, and customer communications.
Supports customer audits and quality-related customer interactions, including product quality complaints.
Manages the company’s calibration and measurement system program to ensure compliance with ISO 13485 and customer requirements.
Supports engineering changes and product development to ensure product quality and regulatory compliance.
Maintains compliance with Pelham Plastics Quality Management System policies and procedures. Adheres to ISO 13485 and FDA QMSR requirements for Quality Management Systems.
Performs all other duties as required or assigned.