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Verathon
Bothell, WA, United States
Company Overview Verathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume meas
Job Source: VerathonAmazon.com, Inc.
Bellevue, WA, United States
DESCRIPTION The Amazon Devices & Services group delivers delightfully unique Amazon experiences. Starting with the best-selling Kindle family of products, we continue to produce groundbreaking devices like Fire TV, Fire tablets, Kuiper, Ring, Alexa, and services like Luna and Amazon Kids. The Data Governance and Privacy Compliance team supports th
Job Source: Amazon.com, Inc.Amazon
Seattle, WA, United States
Description The Amazon Devices & Services group delivers delightfully unique Amazon experiences. Starting with the best-selling Kindle family of products, we continue to produce groundbreaking devices like Fire TV, Fire tablets, Kuiper, Ring, Alexa, and services like Luna and Amazon Kids. The Data Governance and Privacy Compliance team supports the
Job Source: AmazonMicrosoft
Redmond, WA, United States
Compliance Technical Program Manager II - Compliance Microsoft Every company has a mission. What's ours? To empower every person and every organization to achieve more. We believe technology can and should be a force for good and that meaningful innovation contributes to a brighter world in the future and today. View company page Microsoft i
Job Source: MicrosoftPyramid Consulting, Inc.
Redmond, WA, United States
Immediate need for a talented Senior Compliance Specialist. This is a 12+ months Contract opportunity with long-term potential and is located in Redmond, WA(Travel up to 25%) travel would be in the US Please review the job description below and contact me ASAP if you are interested. Job ID: 23 - 40507 Pay Range: $70 - $75/hour. Employee bene
Job Source: Pyramid Consulting, Inc.LVI Associates
Seattle, WA, United States
A top-tier employee-owned consulting firm is seeking a highly skilled and experienced Principal Environmental Compliance Specialist to join the team in Seattle. As a leading authority in environmental compliance, you will play a pivotal role in ensuring this company's adherence to environmental regulations and standards. You will lead efforts to as
Job Source: LVI AssociatesPalantir Technologies
Seattle, WA, United States
A World-Changing Company Palantir builds the world’s leading software for data-driven decisions and operations. By bringing the right data to the people who need it, our platforms empower our partners to develop lifesaving drugs, forecast supply chain disruptions, locate missing children, and more. The Role Palantir Technologies is seeking a Qualit
Job Source: Palantir TechnologiesInventprise Inc.
Woodinville
Job Description Job Description Salary: $33.00 - $38.00 Title : Manufacturing Compliance Specialist Overtime Status: Non-Exempt Employment Status: Full-Time Pay Range: $33.00 - $38.00 /hourly DOE The hiring pay range for this position is $33.00 - $38.00 per hour based on skills, education, and experience relevant to this role. Inventprise
Job Source: Inventprise Inc.Bothell, WA, United States
Verathon, Inc. Compliance Specialist II Bothell , Washington Apply Now Compliance Specialist IILocationUS-BothellID2024-1244CategoryQuality Assurance/Regulatory AffairsPosition TypeFull-TimeWork ModelHybridCompany OverviewVerathon is a global medical device company focused on supporting customers by being their trusted partner, delivering high-quality products that endure over time and ensure clinical and economic utility. Two areas where Verathon has significantly impacted patient care, and become the market leader in each, are bladder volume measurement and airway management. The company's BladderScan portable ultrasound and GlideScope video laryngoscopy & bronchoscopy systems effectively address unmet needs for healthcare providers and meaningfully raise the standard of care for patients. Verathon, a subsidiary of Roper Technologies, is headquartered in Bothell, Washington, USA and has international subsidiaries in Canada, Europe and Asia Pacific. For more information, please visit www.verathon.com.OverviewVerathon is looking for a Regulatory Compliance Specialist to become the newest member of our QA/RA Team located in Bothell, WA.The Regulatory Compliance Specialist is responsible for assuring the Quality Management System is maintained in a state of readiness to applicable regulations and directives such as FDA 21CFR820; ISO 13485; EU Medical Device Regulations (MDR); Canada Medical Device Regulation (CMDR); Australia Therapeutic Goods Act (TGA); Brazil National Health Surveillance Agency (ANVISA); Japan Pharmaceutical Affairs Law (JPAL); and to corporate standards as applicable.Responsibilities* Perform internal audits to determine compliance with Quality Management System standards, policies, and procedures, as well as regulatory and customer requirements under the direction of the Sr. RC Specialist* Assist the Sr. RC Specialist in generating audit reports, tracking responses, recommending corrective action plans, and verifying implementation effectiveness of QMS corrective and preventive actions* Prepare and/or coordinate regulatory field action assessments (e.g. Health Hazard Evaluations) following established procedures* Provide support for FDA and other governmental or ISO Notified Body inspections, including pre- and post-inspection support* Assist with corrective action and remediation plans, as necessary under the direction of the Sr. RC Specialist* Investigate and develop solutions to procedure and process-related issues* Consult with management and cross-functional partners to help formulate and implement proactive regulatory compliance strategies and controls* Participate and lead project teams to improve processes at both local and global levels* Assist in the execution and distribution of standard metric reports, preparation of compliance input for management reviews, maintains company compliance scorecard and related documentationQualifications* Bachelor's Degree in a Scientific or Engineering field or equivalent work experience* 2+ years' experience in a Food and Drug Administration or equivalently regulated environment* Knowledge of QSRs, ISO 13485, MDR, CMDR, TGA, and JPAL requirements is required* Certified Lead Auditor strongly preferred (ASQ CQA)* Knowledge of Design Controls and Sterilization preferred* Experience supporting external audits such as FDA, Notified Body, or customer audits preferred* Able to complete regulatory reports and provide written correspondence to internal and external customers including regulatory bodies* Must have excellent oral and written communication skills. Must have the ability to handle confidential data.* Experience or training in Process Excellence and Six Sigma tools and methodologies preferred* Must be a critical thinker, detaile
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Compliance Specialist II jobs in Bothell, WA, United States
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