Quality Engineer 2 - Cube hub
Issaquah, WA
About the Job
Description:
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 Client Healthineers 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 Client Healhtineers 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.
Requirements
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.
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 Client Healthineers 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 Client Healhtineers 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.
Requirements
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.
Additional Details
- Quality Engineer 2|WA
- Does this worker qualify for overtime? : Yes
- Scorecard Category : Engineering
- Commercial Title : Quality Engineer
- Is this position for a pre-identified (PAYROLLED) candidate? : RECRUITED
- If this is a pre-identified (PAYROLLED) candidate, please see note below and provide the following: : Name: Email Address: Phone Number: Pay Rate: Please also attach the pre-identified candidate's resume
- Will this contingent worker require a computer or systems access or utilize a timeclock? : Yes
- Time System : Fieldglass
- Timeclock/Shift : (SOW ONLY) Not applicable - this is not a T&M SOW|1
- Enter Shift Start and End Time : AM
- Is there potential for this to convert to a full time position? : Yes
- Non-Employee Class : Temporary Agency Worker
- Will the worker be required to travel for Client? : No
- Is there potential for this assignment to be extended beyond 13 weeks? : Yes
- Type of assignment : Full-time
- Will this position require a DEA background check clearance? : No
- Healthineers Vaccination Statement : Healthineers positions within applicable states require candidates to be fully vaccinated or obtain approval of special medical or religious exemption within three days of worker start date.Currently not applicable in the following states: Alabama, Florida, Iowa, Kansas, Montana, North Dakota, Tennessee, Texas, and Utah. States subject to change
Source : Cube hub