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Quality & Regulatory Manager

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Fluke Health Solutions
📍 sweden, Sweden
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Location sweden
📅
Posted June 09, 2026
🚗
Commute Local Area
🎯
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Job Description

Responsibilities

  • Leads and participates in formal problem-solving processes, conducts root cause and corrective action investigations for quality failures, including those occurring in supplier, in-house processes, and Client-side findings.
  • Supports the Director, RAQA for all Quality and Regulatory plans, actions, implementation, and upskilling as the Business grows.
  • Leads overall site compliance efforts. Regulations in scope: FDA applicable to class I and class II medical devices including 510k clearances. Prepare documentation for regulatory meetings with the FDA.
  • Completion of essential functions includes the effective application of Gage R&R Studies, Design of Experiments, Failure Mode and Effects Analysis, Statistical Process Control, the determination of Operating Characteristics for Sampling Plans, and statistical analysis to effect quantifiable product and process improvements.
  • Implements process and softwar...

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    📍 Location Details

    🌆
    City
    sweden
    🗺️
    Country
    Sweden
    🚗
    Commute
    Local Area

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