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Quality Engineering Manager

Lorven Technologies, Inc.Reedsville, PA🇺🇸United StatesPosted 11 Sept 2026

Why This Role Stands Out

Elevate your career in medical device quality with this hybrid Quality Manager role, offering a chance to significantly impact product excellence and compliance. You'll thrive here if you possess a strong background in QMS, CAPA, and regulatory standards like FDA 21 CFR Part 820 and ISO 13485, and are eager to contribute to a reputable company. This is a fantastic opportunity to apply your expertise and grow within a dynamic engineering environment.

Quick Overview

Seniority
Mid Senior
Work mode
Hybrid
Location
Reedsville, PA, United States
Posted
20 hours ago
Stakeholder Management

Job Description

Our client is looking Quality Manager for Contract project in Hybrid  is the detailed requirements.

Job Title : Quality Manager-(Hybrid)
Location : Reedsville, PA
 

Job Description:

  • Bachelor’s degree in related field
  • Strong experience with Medical Device Quality Management Systems (QMS).
  • Expertise in CAPA, Nonconformance, Complaint, and Audit Management.
  • Strong knowledge of FDA 21 CFR Part 820 / QMSR and ISO 13485.
  • Experience with Risk Management and Design Controls.
  • Strong background in Quality Metrics, Remediation, and Compliance Programs.
  • Experience supporting FDA inspections and regulatory audits.
  • ISO 13485 Lead Auditor, ASQ, or CQI certification preferred.
  • Strong documentation, communication, and stakeholder management skills.

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