Medical Device Quality Engineer
2 weeks ago
5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries.
Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FDA CFR 21 820 and ISO 13485.
Familiarity with product development lifecycles, including design change and document change control.
Competence in process verification and validation methodologies.
Proficient in using word processing, spreadsheet, and presentation software.
Knowledgeable about continuous quality/process improvement tools.
Strong understanding of regulatory compliance within the medical device/pharmaceutical sectors.
Ability to analyze and interpret quality data to drive improvements.
Excellent communication and interpersonal skills.
Desired Job Titles: Senior Quality Engineer, Quality Assurance Engineer, Medical Device Quality Specialist, Regulatory Compliance Engineer, Quality Control Engineer, Validation Engineer, Process Improvement Engineer, Supplier Quality Engineer, Manufacturing Quality Engineer
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