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Quality Manager - Medical Devices

Resource LogisticsReedsville, PA🇺🇸United StatesPosted Sep 29, 2026

Why This Role Stands Out

This hybrid Rhapsody Integration role offers excellent career growth with a competitive salary of $135,000 - $155,000, allowing you to leverage your expertise in HL7, FHIR, and various APIs within a reputable company. You'll thrive if you're a skilled integration specialist eager to contribute to impactful projects and enjoy a flexible work arrangement with occasional travel. Don't miss this opportunity to advance your career and apply today!

Quick Overview

Salary
$135k - $155k/yr
Seniority
Mid Senior
Work mode
On Site
Location
Reedsville, PA, United States
Posted
1 week ago

Job Description

Job Title: Quality Manager - Medical Devices
Locations: Reedsville PA (Onsite) & Bothell WA (Onsite)
Job Type: Fulltime
Total Openings: 2
Salary: $130000 - $150000 per annum + Benefits
Job Description:

Lead quality remediation and compliance programs for medical devices, ensuring adherence to FDA, ISO 13485, and global regulatory requirements. Provide leadership for QMS processes, audit readiness, CAPA governance, quality metrics, and continuous improvement initiatives across cross-functional teams.

  • Lead QMS, CAPA, Nonconformance, Complaint, and Audit programs.
  • Support FDA inspections and regulatory audits.
  • Drive quality remediation and compliance initiatives.
  • Monitor quality metrics and management reviews.
  • Lead cross-functional quality improvement activities.
  • Medical Device Quality Management Systems (QMS).
  • CAPA, Nonconformance, Complaint, and Audit Management.
  • FDA 21 CFR Part 820/QMSR and ISO 13485.
  • Risk Management and Design Controls.
  • Quality Metrics, Remediation, and Compliance Programs.
  • Medical Device Quality experience.
  • Quality Management leadership experience.
  • ISO 13485 Lead Auditor or ASQ/CQI certification preferred.
  • Experience supporting FDA inspections and remediation programs

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