Quality Engineer
Company: The Judge Group
Location: Issaquah
Posted on: April 18, 2024
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Job Description:
Our client is currently seeking a Quality Engineer for a 12
month + contract.
Position Description: JOB SUMMARY:The Quality Engineer processes,
investigates, and monitors trending and reporting of medical device
product defect complaints, overseeing the documentation and
resolution of customer reports and complaints in accordance with
company.
Ultrasound policies and procedures to ensure compliance with global
regulatory agency reporting requirements. This includes but is not
limited to complaint handling, adverse event reporting, returned
product disposition, and analyzing data for monitoring and
optimization activities. This position may also involve
interactions with customer service, production, engineering and
clinical research.ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: Ensure
all work is performed in compliance with company policy and within
the guidelines of their 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 Quality Manager or from the
department head.Generate and submit medical device event reports to
appropriate authorities and government agencies as requested and as
required by applicable global laws and regulations.KNOWLEDGE,
SKILLS AND ABILITIES: Experience in Medical Complaint Handling;
familiarity with Quality System Regulations (21 CFR 820.196) and
ISO 13485. Must be able to adapt to change in the workplace and
demonstrate flexibility with new ideas. Good understanding of
operational environment and analytical skills. Must be
self-motivated and a good team player. Exceptional organization
skills and attention to detail. Ability to preform job function
with minimal supervision and work independently taking initiative
to make independent decisions, where appropriate. Proficiency in
using Microsoft Office Applications (MS Word, MS Excel, MS PP, MS
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) Additional professional certifications are a
plus.
Keywords: The Judge Group, Shoreline , Quality Engineer, Engineering , Issaquah, Washington
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