Kelly Services Quality Assurance Specialist in Snoqualmie, Washington
Kelly Science is the world’s most recognized brand in Scientific Staffing with more than 100 locations in North America, Europe, and the Pacific Rim. We are currently hiring a Quality Assurance Specialist for a medical device company in the Snoqualmie, WA area.
The Quality Assurance Specialist will ensure that the quality management system for the organization is in compliance with 21CFR Part 820, ISO 13485 and other relevant standards. The incumbent will implement and maintain the organization's database that will be used to satisfy the FDAs Global Unique Device Identification (UDI) system. They will also plan, coordinate, data gather, populate and maintain the Global UDI Database (GUDID); providing coverage to the global product offerings that are under the review scope of the FDA. The incumbent will provide guidance to various workflows and work cross functionally to assure compliance with all applicable regulations as part of growth and improvement initiatives.
Research and work inter-departmentally to source information required to populate all attributes of the organization's GUDID that are determined to be required for every product. Performing revisions as needed throughout the product life cycle.
Support Regulatory Affairs with any GUDID data required for new submissions to the FDA. This may involve future support for RA submissions to other countries.
Collaborate with subject matter experts on projects and advise the level of qualifications and/or validation needed to ensure compliance with applicable regulations.
Prepare, coordinate, and review documentation required to verify accuracy of new/revised UDI data elements before inclusion in the GUDID.
Review, manage, and execute quality plans related to GUDID system requirements/changes.
Serve as a primary contact for trouble-shooting any database issues. This includes maintaining operation of the database/software/FDA connection portal.
Ensure all documentation generated on projects adheres to chance managements processes.
Track and trend status on UDI program metrics.
Assess and provide input on GUDID related requirements
Support the Quality Management System that establishes and maintains effective quality assurance processes and compliance to applicable International Standards.
Perform any other duties related to job position as assigned.
Bachelor of Science in Engineering, Biomedical Sciences, Computerized Systems or equivalent professional experience
3+ years of experience with GUDID programs in and FDA regulated environment or equivalent
6+ years of experience within a medical device quality management system
Ability to communicate effectively with staff at all levels of the organization
Ability to manage activities and initiatives through timelines to meet corporate goals
Demonstrated excellence in planning, executing, and project management
ASQ certification in ISO 13485 and 21CFR 820 compliance of medical devices
Understanding of six sigma methodology
Experience under design control and Good Manufacturing Practices (GMP)
Proficiency with Microsoft Office, Oracle Agile PLM, or ComplianceWire
Pay rate: $45/hr; can provide more incentive based on experience
Shift: Monday- Friday, 8:00am - 5:00pm
Duration: 6 month contract
Note : To comply with applicable government requirements, all U.S. employees must be fully vaccinated against Covid-19 unless they are entitled to and approved for a legal accommodation, in accordance with the company's Covid-19 Vaccination Policy.
You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.
Why Kelly ® ?
Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.
About Kelly ®
At Kelly, we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)