BASIC FUNCTION
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.
PRINCIPLE DUTIES AND 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.
MINIMUM REQUIREMENTS
EDUCATION: Bachelor's degree in a related engineering discipline or equivalent
EXPERIENCE:
5+ years of Quality Engineering experience in medical device or other regulated manufacturing environment.
SPECIAL SKILLS:
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.
PHYSICAL REQUIREMENTS:
Able to lift up to 20 lbs; sit, stand, bend and stoop; good visual acuity and capable of fine motor skills.
