Medical Device Auditor - ISO 13485/MDSAP (Travel)
SGS North America Inc.
SGS North America Inc. is seeking a Contract Medical Device Auditor to perform third-party audits of client quality systems to ISO 13485 and other regulatory standards. The role requires travel to the United States, Canada and Mexico up to 80% of the time. You will evaluate evidence gathered during audits, make certification recommendations, and maintain credentials while adhering to SGS procedures and industry standards. #J-18808-Ljbffr SGS North America Inc.
- ...Medical Device Auditors - Full-time - Travel Based Auditor Interested in future career opportunities in the Quality Assurance audit and support services... ..., and other relevant standards, specifically ISO 13485, regulatory requirements for the US, Canada, Japan, Australia...TravelMedical deviceFull timeWork experience placementRemote workNight shift3 days per week
- ...Contract Lead Certification Auditor and play a critical role in ensuring... ..., and Personal Care (PCPC)/Medical Devices performs third-party audits... ...role - must be authorized to travel to and provide auditing... ...more than one standard (i.e. ISO 22716, EU GMP, WHO GMP/GDP, EFfCI...TravelMedical deviceContract workWork experience placementWork at officeLocal areaWeekend work
$85k - $95k
Company Overview: Argon Medical Devices is a global manufacturer of specialty... ...ensuring compliance with ISO/GMP/FDA and quality standards... ...cGMP compliance and promote ISO 13485 quality standards.... ...industry Physical demands & Travel required Light Base Salary...TravelMedical device$154k - $231k
...compliance as measured by FDA/ISO/internal audits.... ...to the design/operation of medical device or drug combination product... ...industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR). At least 4 years... ...table). Position requires travel up to 30% of the time for business...TravelMedical deviceMinimum wageWork experience placementLocal areaWorldwide$177k - $266k
...~ At least 7 years of experience in medical device, pharmaceutical, drug combination product... ..., including 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and MDR. ~ Proficiency in analyzing... ...management. Position requires travel up to 30% of the time for business...TravelMedical deviceMinimum wageContract workFor contractorsWork experience placementLocal areaWorldwide$126k - $175k
...regulatory agencies regarding device information or issues.... ...including those for medical devices products. 7.... ...external audits, including ISO and/or regulatory body... ...duties as assigned.Travel Percentage: <25%Physical... ...devices (21 CFR 820, ISO 13485, ISO 14971, CMDR)....TravelMedical deviceWork at officeWorldwide$116k - $174k
...regulations (ex. QSR, GMP,ISO) pertaining to the applicable... ...to the design/operation of medical device or drug combination product... ...industries (21CFR 820, ISO 13485, ISO 14971, MDSAP, and MDR). Knowledge /... ...table). Position requires travel up to 25% of the time for business...TravelMedical deviceMinimum wageWork experience placementWork at officeLocal areaWorldwide- ..., color, family or medical care leave, gender... ...effectiveness of the ISO quality system as... ...validated processes and Device Master Records, as... ...with ISO 13485, FDA 21CFR820, and... ...Certified ISO 13485 Auditor or similar certification... ...high-quality results. Travel & Work Arrangements...TravelMedical device
$86.7k - $173.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic... ...in Buffalo Grove, Illinois.** Up to 15% travel, including domestic and international *... ...of FDA, GMP, ASTM standards, PPWR and ISO 13485 guidelines + Experience with equipment...TravelMedical deviceWork experience placementWorldwide- ...domestic and international medical device regulations. This role develops... ..., including FDA, UL, ISO 13485, customer, corporate, and notified... ...(RAC), Internal Auditor Certification, Six Sigma, or... ...and Six Sigma methodologies.Travel Requirements:Ability to travel...TravelMedical device
$234k - $351k
...Engineering, or a related function within medical device, pharmaceutical, healthcare products,... ...of applicable FDA requirements, ISO 13485, EU MDR, and other global quality and... ...business objectives. ~ Position requires travel up to 35–50% for business purposes, including...TravelMedical deviceMinimum wageWork experience placementLocal areaWorldwide$101k - $152k
...develops, and supports complex medical devices with a focus on electrical... ...testing (IEC 60601, IEC 62304, ISO 14971).Experience with... .../ AbilitiesPosition requires travel up to 10% of the time for business... ...Series, FDA 21 CFR Part 820, ISO 13485, and ISO 14971.Effective...TravelMedical deviceMinimum wageFull timeLocal areaWorldwide$309k
...compliance with FDA regulations, ISO standards, and applicable... ...or a related function within medical device, pharmaceutical, healthcare products... ...FDA requirements, ISO 13485, EU MDR, and other global quality... .... ~ Position requires travel up to 50% for business...TravelMedical deviceMinimum wageWork experience placementLocal areaWorldwide$86.7k - $173.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...PpK data.Familiarity with cGMP, FDA and ISO regulated environment.Experience in work... ...would be an advantage.Ability to travel approximately 15%, including internationally...TravelMedical deviceWorldwideShift work$100k - $125k
...portfolio which includes inhalation devices, injection devices, nasal and... ...Assist in maintaining ISO and FDA QMSR quality system compliance... ...position Experience in the Medical Device industry preferred... ...cleanroom apparel Up to 40% travel required ADDITIONAL...TravelMedical deviceContract workWork at officeWorldwideShift work$96.5k
...issues today and address the medical challenges of tomorrow. We strive... ...of innovative drug-device combination products within our... ...standards (e.g., 21 CFR 820.30, ISO 13485, MDR) Understanding of modern... ...Additional Information Travel (domestic and/or international...TravelMedical deviceTemporary workLocal area$78k - $156k
...and products in diagnostics, medical devices, nutritionals and branded... ...accordance with business standards.Travel up to 25% domestically to... ...Strong working knowledge of ISO 13485 and regulatory requirements... ...authority.Certified Lead Auditor trained.Apply NowLearn more...TravelMedical deviceWork experience placementWorldwideShift work$30 - $40 per hour
...Manager update : 1. Packaging design development for medical devices or pharma industry 2. Packaging verification and validation... ...of experiments. • Knowledge of the following standards: ISO 11607, ISO 13485, ISO 14971 Accountability: •Will not manage any direct...Medical deviceContract workTemporary workFor contractorsWork at officeWork from homeFlexible hoursDay shift- ...Job Description Job Description Medical Device Intake & Processing Technician – 2nd Shift Shift: Monday–Friday, 12:00 PM–... ...quality and regulatory requirements, including: HIPAA ISO 13485 OSHA Joint Commission standards Good Documentation Practices...Medical deviceTemporary workLocal areaMonday to FridayShift workAfternoon shift
- ...design and development processes in an ISO 9001 and 13485 business management system. Provide... ...required. Domestic and International travel is required for this position. Remote... ...specializing in converting solutions for medical devices, automotive components, aerospace...TravelMedical deviceContract workRemote work
$115k - $150k
...About Alma Lasers**Alma, a Sisram Medical company, is a global leader in... ...of experience in energy-based devices (EBD). Operating in more than... ...-based work and may require travel up to 50%.**Essential... ...preferred.* Experience working in an ISO-certified or regulated quality...TravelMedical deviceFull timeWork at officeWorldwide$108k - $155k
...product development projects, ideally in the medical device field Education Requirements Bachelor's degree... ...device environments (e.g., 21 CFR, QSR 830, ISO 13485, ISO 14971, Risk Management) preferred. Up to 15% travel. Key Skills and Experience Product Development...TravelMedical deviceWork experience placementWork at officeVisa sponsorship- ...issues today and address the medical challenges of tomorrow. We strive... .... Products include medical devices and combination products,... ...individuals. ~ Working knowledge of ISO 13485, ISO 14971, 21 CFR 4, 21 CFR... ...environment ~ Able to travel up to 10% of the time....TravelMedical deviceFull timeContract workLocal areaWorldwide
- ...DescriptionJob SummaryResponsible for leading and developing teams of auditors in the execution of multiple complex IT, operational,... ...year of cross-functional team leadership experience.Willing to travel up to 30% of the time for business purposes (domestically and/or...TravelHourly pay
- ...issues today and address the medical challenges of tomorrow. We strive... ...successful development of device and delivery systems. This... ...standards (e.g., 21 CFR 820.30, ISO 13485, MDR, etc.). Solid R&D... ...layers of the organization. Travel (domestic and international)...TravelMedical deviceContract work
$86.08k - $129.12k
...every day at Zebra.What We're Looking For:The Senior Internal Auditor serves as an advisor to the business and leads the planning and... ...hybrid (3 days in office/2 remote) from Lincolnshire, IL. Able to travel up to 25% travel domestic and international Minimum...TravelFull timeWork experience placementSummer workWork at officeLocal areaRemote workFlexible hours- ...and staff and ensure mentoring for high potentialsPotential to travel domestically and/or internationally (limited, potentially 10-20%... ...preferredExperience with leading IT risk frameworks such as NIST, COBIT, ISO 27001, FAIRProject management experience and ability to apply...TravelLocal area
- ...experience, including time spent in a specialty role or selling medical equipment/devices or High School Diploma/GED and at least 10 years of... ...leadership and/or cross-functional team leadership.Willing to travel at least 75% of the time for business purposes (within state...TravelMedical deviceHourly payWork at officeLocal areaRemote work
- ...Job Title: Associate Medical Device Sales Representative Location:Multiple Territories Nationwide (Field-Based / Territory-Based) Position... ...: Must possess a valid driver's license and the ability to travel up to 50% locally within your designated territory. Ability to...TravelMedical deviceFull timeImmediate startFlexible hoursNight shiftWeekend work
- ...independently setting and upholding quality standards for portfolio of medical device, commodity, OTC drug, and/or cosmetic products. Evaluate... ...(e.g. 21 CFR 820, ISO13485). Position requires up to 15% travel. At least 2 years of industry experience in Medical Devices...TravelMedical device
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