NEW JOB OPENING
QUALITY ENGINEER
IN ISSAQUAH, WA, USA!

 

Date Posted: 04/12/2024
Hiring Organization: Rose International
Position Number: 462252
Job Title: Quality Engineer
Job Location: Issaquah, WA, USA, 98029
Work Model: Onsite
Shift: Shift 1; M-F
Employment Type: Temp to Hire
Estimated Duration (In months): 7
Min Hourly Rate($): 35.00
Max Hourly Rate($): 40.00
Must Have Skills/Attributes: 21 CFR part 11, Computer Literacy, Customer Service, ISO 13485, Medical Terminology, Minitab, Quality Engineer, SAP

 

Job Description

  • **Only those lawfully authorized to work in the designated country associated with the position will be considered.**

  • **Please note that all Position start dates and duration are estimates and may be reduced or lengthened based upon a client’s business needs and requirements.**

Per client: "The hiring manager is looking for experience managing customer complaints as well as 21 CFR 820.196) and ISO 13485 compliance."

Description:
• 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 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 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 perform 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, Mini Tab, and SOP writing is a plus.

EDUCATION AND EXPERIENCE:
• Bachelor's Degree required, Master's degree highly desired
• 3+ years of professional experience in complaint handling and Quality Assurance in the medical device industry.
• Familiarity with Quality System Regulations (21 CFR 820.196) and ISO 13485 required,
• Additional professional certifications are a plus.

 

Benefits:
For information and details on employment benefits offered with this position, please visit here. Should you have any questions/concerns, please contact our HR Department via our secure website.

California Pay Equity:
For information and details on pay equity laws in California, please visit the State of California Department of Industrial Relations' website here.

Rose International is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender (expression or identity), national origin, arrest and conviction records, disability, veteran status or any other characteristic protected by law. Positions located in San Francisco and Los Angeles, California will be administered in accordance with their respective Fair Chance Ordinances.

If you need assistance in completing this application, or during any phase of the application, interview, hiring, or employment process, whether due to a disability or otherwise, please contact our HR Department.

Rose International has an official agreement (ID #132522), effective June 30, 2008, with the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services, Employment Verification Program (E-Verify). (Posting required by OCGA 13/10-91.).

 

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About Rose

  • Founded in 1993
  • Office Locations Across the U.S.
  • 150+ Clients: Corporations and Government Agencies
  • Employee Oriented Company
  • Challenging Assignments Across the U.S.
  • Continuous Professional Development

My on-boarding with Rose was outstanding. The packets of information, the process, and great attention to detail each person gave me allowed me to get started quickly.I appreciated each person's friendly and helpful attitude.

Diana, Consultant

It was great working for Rose International. Everyone was extremely helpful.

Rosann, Consultant

Rose International has been great to me. I thank everyone there for all of their hard work; it has not gone unnoticed.

Melody, Consultant

It is a great pleasure being a part of the Rose International Team.

Toni, Consultant

You are customer service oriented. No matter whether it was the Recruiter or someone in Human Resources/Payroll, you were responsive. That to me is key!

Tonya, Consultant

EMPLOYEE COMMENTS

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