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Acara Solutions Quality Engineer in Issaquah, Washington

Description Are you a Quality Engineer who is looking to join one of the top companies within the Manufacturing Industry? Are you looking to further your career and grow? Do you have experience upholding Quality System Regulations (21 CFR 820.196) and ISO 13485. If you answered yes to those three questions, then apply today! Acara Solutions is seeking highly qualified candidates to work ON-SITE with our client in Issaquah, WA. Interested? Here's what you'd do: 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 by 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 also involves interactions with customer service, production, engineering, and clinical research. 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 by the department head. Generate and submit medical device event reports to appropriate authorities and government agencies as requested and as needed by applicable global laws and regulations. Here's what you'll get: Pay: $40.00 / hr. Hours: 40 hrs/Week (1st shift) Length: 7 months (perm possible) Sound like a good fit? APPLY TODAY About Acara Solutions Acara is a premier provider of recruiting and workforce solutions-we help companies compete for talent. With a legacy of experience in a variety of industries around the world, we partner with clients, listen to their needs, and customize visionary talent solutions that drive desired business outcomes. We leverage decades of experience to deliver contingent staffing, direct placement, executive search, and workforce services worldwide. Job Requirements Required Skills / Qualifications: Bachelor's Degree Minimum of 3 years experience in Medical Complaint Handling Minimum of 3 years Quality Assurance experience in the medical device industry including Quality System Regulations (21 CFR 820.196) and ISO 13485. Preferred Skills / Qualifications: Master's Degree Experience with SAP, Minitab, and SOP writing Able to adapt to change in the workplace and demonstrate flexibility with new ideas. Good understanding of the operational environment and analytical skills. 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). Additional Information: Upon offer of employment, the individual will be subject to a background check and a drug screen. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Aleron companies (Acara Solutions, Aleron Shared Resources, Broadleaf Results, Lume Strategies, TalentRise, Viaduct) are Equal Employment Opportunity and Affirmative Action Employers. All qualified applicants will receive consideration

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