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Quality Engineer
3 months ago
Seeking a dedicated professional to support the maintenance and compliance of our Quality Management System in accordance with ISO 13485, regulatory bodies, and customer agreements. The ideal candidate will define requirements for new products, monitor production quality performance, and maintain quality files, procedures, and work instructions.
Essential Duties
Evaluate specifications and design documents to provide feedback.
Develop and coordinate validation plans using the IQ OQ PQ framework.
Ensure validation documentation meets regulatory and internal standards.
Conduct FMEAs and risk assessments with internal and external teams.
Investigate root causes of non-conformances and implement corrective actions.
Analyze quality data to identify areas for improvement.
Support new product development and production processes.
Requirements
Bachelor's Degree in a related field or 4 years of quality engineering experience.
Strong understanding of quality management systems and ISO 13485 compliance.
Experience with validation planning and execution (IQ OQ PQ).
Proficiency in FMEAs, risk assessments, and root cause analysis.
Excellent communication and collaboration skills.
Ability to prioritize and manage multiple tasks effectively.
Quality Engineer - (phone number removed)