Entry-level quality engineering position ensuring medical device products meet established requirements and regulatory standards. The role involves cross-functional collaboration on compliance, documentation, risk management, and continuous quality improvement activities.
Responsibilities
Ensure product compliance with global regulations and quality standards
Review, maintain, and approve Design History Files and Risk Management Files
Identify and mitigate design risks using FMEA and analytical tools
Support design verification, validation, and change control processes
Manage nonconformance records, investigate complaints, and support CAPA activities
Requirements
Bachelor's degree with 1-3 years related experience
Familiarity with 21 CFR 820, ISO 13485, IEC 62304 standards
Experience in regulated industries
Medical device industry experience preferred
Proficiency with MS Office Suite and Adobe software
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