Staff Software Quality Engineer, Post Market Integration

$112.9k - $188.1k

Stryker Orthopaedics

Flower Mound, TX

Responsibilities

Lead complex investigations, root cause analysis, and risk management activities for commercialized products
Drive customer complaint investigations, nonconformance, CAPA, and regulatory quality processes
Partner cross-functionally with customers, commercial teams, operations, R&D to address quality issues
Review change management and development activities to identify risks and drive improvements
Analyze quality metrics to identify trends and improve product reliability and compliance

Requirements

Bachelor's degree in Science, Engineering, or related discipline
Minimum 4 years experience in regulated or technology-driven industry
Proficiency in Software Development Lifecycle processes and methodologies
Strong knowledge of Quality Concepts including Risk Management, CAPA, Audits, Statistics
Ability to work in hospital and clinical environments with required credentials and health clearances
Medical device industry experience with ISO 13485, GDP, GMP knowledge (preferred)
Working knowledge of computer hardware and related technologies (preferred)

Compensation: $112,900 - $188,100 USD Annual

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Vacancy posted 1 day ago

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