Quality Engineer - Issaquah, United States - Cynet Systems

Cynet Systems Issaquah, United States

4 weeks ago

Description

Job Description:
Pay Range $35hr - $40hr

Responsibilities:

Ensure all work is performed in compliance with company policy and within the guidelines of the client Ultrasound Quality System.

Supervise the investigation, resolution, and reporting of all customer-related complaints.
Coordinate with other departments to obtain necessary information/updates for the resolution of complaints.
Undertake and complete assignments as determined by the Quality Manager or department head.

Generate and submit medical device event reports to appropriate authorities and government agencies as requested and required by applicable global laws and regulations.

Knowledge, Skills, and Abilities:
Experience in Medical Complaint Handling; familiarity with Quality System Regulations (21 CFR and ISO 13485.
bility to adapt to changes in the workplace and demonstrate flexibility with new ideas.
Strong understanding of the operational environment and analytical skills.
Self-motivated with excellent team collaboration skills.
Exceptional organization skills and attention to detail.
bility to perform job functions with minimal supervision and work independently, taking initiative to make independent decisions where appropriate.
Proficiency in using Microsoft Office Applications (MS Word, Excel, PowerPoint, Outlook).
Experience with SAP, Minitab, and SOP writing is a plus.

Education and Experience:

3+ years of professional experience in complaint handling and Quality Assurance, preferably in the medical device industry.
Bachelor's Degree (required), Master's Degree (preferred).
dditional professional certifications are a plus.

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