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Quality Lead Engineer (Medical Device Validation)

Lorven Technologies, Inc.Reedsville, PA🇺🇸United StatesPosted Sep 30, 2026

Why This Role Stands Out

This hybrid role offers a fantastic opportunity to lead critical medical device validation efforts within a reputable company, fostering significant professional growth. You'll thrive here if you possess strong quality engineering experience in the medical device sector and are eager to make a tangible impact. Apply today to advance your career in this dynamic field.

Quick Overview

Seniority
Mid Senior
Work mode
Hybrid
Location
Reedsville, PA, United States
Posted
2 days ago

Job Description

Hi,

Our client is looking for Quality Lead Engineer (Medical Device Validation) - Reedsville, PA below is the detailed requirements.

Job Title: Quality Lead Engineer (Medical Device Validation)

Location: Reedsville, PA

Job Description:

  • Bachelor's degree in Computer Science, Information Technology, Engineering, or related field with 8–12 years of overall IT experience.
  • 8+ years of Medical Device Quality experience.
  • Experience with Class II/III medical devices.
  • Experience supporting FDA, MDSAP, and ISO audits
  • Manage CAPA, Nonconformance, and Deviation activities.
  • Conduct Root Cause Analysis and corrective actions.
  • Review quality metrics and identify recurring issues.
  • Support quality audits and FDA readiness programs.
  • Collaborate with cross-functional teams on quality improvements.

Required Skills: 

  • CAPA, Nonconformance, and Deviation Management.
  • Root Cause Analysis (5 Why, Fishbone, FTA).
  • Quality Metrics and Trend Analysis.
  • FDA 21 CFR Part 820, ISO 13485, ISO 14971.
  • Design Controls and Validation Support

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