Lead QA Auditor - ISO 13485 & Regulatory Audits
Boston Scientific - Minnetonka
Boston Scientific is seeking a Senior QA Auditor to lead end-to-end quality audits with emphasis on ISO 13485 compliance. You will develop audit plans, conduct on-site and system audits, write clear reports, and drive corrective actions while supporting external regulatory audits. The role requires 5+ years in medical device quality systems, strong communication, and the ability to collaborate across functions to improve processes and compliance. #J-18808-Ljbffr Boston Scientific
- Insight Global is seeking a QA Internal Auditor for a medical device client in Valencia, CA. This full-time role owns the complete audit lifecycle, developing audit plans, conducting internal... ...supporting external audits to ensure ISO 13485 compliance. You will document...SuggestedFull time3 days per week
$89.2k
About The Role This Senior QA Auditor role focuses on planning, executing... ...and external quality audits, with a strong emphasis on ISO 13485 compliance. The individual will lead audits end to end—... ...managing external audits with regulatory bodies such as the FDA and...RegulatoryHourly payShift work- ...Senior-level experience leading internal audits end-to-end (planning, execution... ...Strong knowledge of ISO 13485 and Quality Management Systems... ...Exposure to global regulatory environments and multi-site... ...industry is seeking a QA Internal Auditor to join their Quality department...RegulatoryPermanent employmentFull time3 days per week
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$32 - $38 per hour
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...quality of products conform to established company and regulatory standards.Use surveillance and auditing techniques to identify opportunities for process and... ...experience with AS9100 and AS9102 (ISO 9001 is desirable but not required)Previous experience...RegulatoryLocal area- Encore Consulting Services, Inc. is seeking a Financial Business Analyst with experience in Oracle applications. This role involves managing the global roll-out of Oracle, developing reports, and enhancing financial processes. The ideal candidate has a bachelor's degree...Contract work
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...Management System (QMS) and regulatory requirements by... ...and helping prepare for audits. The ideal candidate... ...regulatory requirements (ISO 9001, ISO 13485 if applicable, FDA... .... Collaborate with QA, Regulatory, Manufacturing... ...ASQ Certified Quality Auditor (CQA) or similar;...RegulatoryLocal area- ...Management (dFMEA).Test Method Validation.DHR Review & Documentation.New Product Development (NPD).Regulatory Compliance & Quality Systems.Preferred SkillsFDA/ISO 13485 Medical Device Regulations.Product Development Lifecycle.Cross-Functional Quality Support.Experience...Regulatory
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$25 - $35 per hour
...reassessments including program review and functional audits of HACCP, SQF programs, and pre-requisite programs.... .... Keep the plant updated on all HACCP, regulatory and SQF related notices and directives. Lead/participate in projects or activities that modify or...RegulatoryHourly payFull timeTemporary workMonday to Friday- ...an experienced Finance Controller to lead the Hyatt Place Toronto Mississauga Centre... ...excellence. Liaise with external auditors, banks, and regulatory bodies as needed. · Analyzing... ...environment May require extended hours during financial reporting periods or audits...Regulatory
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$67.57 per hour
...execution aligns with business objectives, regulatory requirements, and product development... ...compliance . Key Responsibilities Lead the planning and execution of projects... ...standards, including IEC 62304, ISO 14971, and ISO 13485 . Ensure software lifecycle documentation...RegulatoryContract work- ...technical execution with business objectives, regulatory expectations, and product roadmaps. As... ...product roadmaps. Responsibilities Leading the planning and execution of projects... ...standards (e.g., IEC 62304, ISO 14971, ISO 13485). Ensure proper integration of software...Regulatory
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$145k - $160k
...detailed designs to meet applicable product requirements and regulatory standards that can be reliably produced by manufacturing. Create... ...-4-x, FCC Parts 15, FDA QR Title 21 CFR 820 (Medical System), ISO 13485, ISO 14708-1, ISO 14708-3, IEC 62133-2 for battery, etc. ASIC...RegulatoryFull timeWork experience placementFlexible hoursWeekend work- ...and accountable accountant to lead their valued Finance team and... ...and support the financial & regulatory reporting Manage escalations... ...work with internal and external auditors to ensure a controlled SOX... ...environment and substantive audits Continuously improve our processes...RegulatoryWork from home
$130.7k - $261.3k
...spans the spectrum of healthcare, with leading businesses and products in diagnostics,... ...Opportunity We are recruiting for a Senior Regulatory Affairs Manager to join our Digital... ...requirements, including FDA regulations, EU MDR, ISO 13485, and other regional requirements.Manage...RegulatoryWork experience placementWorldwideShift work- ...procedures to meet internal and external regulatory requirements. Provides expertise and... ...deliverables. Demonstrate the ability to lead, acknowledge, develop, communicate & implement... ...requirements including 21 CFR 820, ISO 13485, CFR Part 11 for Medical Devices. Must...RegulatoryVisa sponsorshipWork visaFlexible hours
$100.32k - $150.48k
...with 21CFR820, ISO13485, ISO 14971, IEC 60601, MDSAP... ..., quality, resources)Leads simulation of design concepts... ...4971, IEC 60601-1, ISO 13485, particular standards,... ...specifications, regulatory requirements, and international... ...during and outside of audits. Proven ability to work...RegulatoryTemporary workWork at officeRemote workFlexible hours3 days per week
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