Quality Assurance Coordinator — Medical Devices (ISO 13485)
The West Group Ltd
The West Group USA in Garland, TX seeks a Quality Assurance Coordinator to lead incoming inspection, maintain process validation, and act as the site quality systems keeper. You will coordinate with production, shipping, and corporate quality to ensure product conformity and regulatory compliance. This non-management role requires meticulous attention to detail, strong communication, and the ability to work independently while interfacing with multiple teams across the site and corporate #J-18808-Ljbffr The West Group Ltd
Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Quality Assurance Coordinator — Medical Devices (ISO 13485) in Garland, TX vacancy
- ...West Group USA is a growing medical manufacturing company in Garland, TX, seeking a Quality Assurance Coordinator. This position is the key site... ...the organisation. Lead ISO 13485 and customer quality audits... ...manufacturing environment (medical device strongly preferred). Hands-...Medical deviceWork at office
- ...efficiently to produce high quality products. He/she will also be... ...in a pharmaceutical and/or medical device industry. ~ Certified Quality... ...of FDA regulations, cGMP, ISO 13485, ICH guidelines and risk... ...greater team. Must be able to coordinate work with customers,...Medical deviceWork experience placement
Mativ
Dallas, TX2 days ago - ...customer service and short lead times. We are an ISO 9001 2016 organization with a 13485 certification for the medical and pharmaceutical industry.The ideal candidate... ...experience selling plastic packaging in the medical device industries, QualificationsProven track record of...Medical deviceFull timeFlexible hours
Technipaq
Dallas, TX3 days ago - ...we are committed to driving innovation, quality, and speed. With multiple manufacturing facilities... ...! Paid Time Off, 401K Matching, Medical, Dental, and Vision Benefits! High-... ...Familiarity with quality tools and FMEA, PAPP, ISO 9001, etc. Formal lean manufacturing...Suggested
Maverick Power
Garland, TXa month ago - ...Design Engineer-Spine/Spinal Medical devices Location: Dallas, TX 75... ...Research & Development, Quality Assurance, Manufacturing, and Regulatory... ...820 . Work within an ISO 13485-compliant quality system... ...functional stakeholders. Coordinate engineering activities to meet...Medical devicePermanent employmentFull timeContract workTemporary workLive inWork at officeRelocationMonday to Friday
W3Global Inc.
Dallas, TX5 days ago - ...Manager, Quality Engineering Manages the Quality Engineering team... ...requirements and MDSAP (FDA, ISO, EU MDR, ANVISA, MHLW, and... ...Excellent working knowledge of medical device regulations and industry... ...manufacturing (FDA 21 CFR Part 820, ISO 13485, EU MDR (2017/745), the...Medical device
Nordson MEDICAL
Parker, TX5 days ago - ...Theragenics is a leader in developing medical devices that focus on minimally... ...Compliance: Partner with Quality, Engineering, Operations,... ...Regulation (21 CFR Part 820), ISO 13485, EU MDR, MDSAP, and... ...regulations. Regulatory Submissions: Coordinate the preparation, assembly,...Medical deviceWork experience placement
$40 - $42 per hour
...Experience providing quality oversight of software... ...regulated industry (e.g., medical device, pharmaceutical,... ...CFR Part 820, EU MDR, ISO standards). Reviews... ...Engineering or Quality Assurance oversight for Non-Product... ...Device Directive, ISO 13485/14971 guidelines and...Medical deviceShift workExperis/Manpower Group
Plano, TX5 days ago- ...Ensure compliance with FDA 21 CFR Part 820, ISO 13485, and GMP regulations. Partner with R&D, Quality Assurance, and external vendors to scale up pilot lines... ...years of equipment validation experience within medical device manufacturing. ~ Strong understanding of...Medical device
Katalyst Healthcares and Life Sciences
Dallas, TX5 days ago - ...to improve efficiency, reduce cost and improve quality. In collaboration with the production team,... ...and technical standards (IPC, JIT, Lean etc.) ISO 9001 and ISO 13485 experience preferred. AS9100 and /or medical device manufacturing experience is an asset. Ability...Medical deviceLocal area
Creation Technologies International Inc
Dallas, TX28 days ago - ...lifecycle.Regulatory and Quality report to the... ...compliance audits (e.g. FDA, ISO, etc.) and actively participate... ...including, ISO 13485, ISO 14971, IEC 60601-... ...development.• Ensure procedural, medical, scientific, and... ...II software medical device organization• Familiarity...Medical device
- Job Description About the Role The Quality Engineer serves as a key quality and regulatory... ...in compliance with FDA and applicable ISO standards. Ensure validation... ...Corrective and Preventive Action (CAPA) ISO 13485 Medical device quality management systems ISO 11135 Ethylene...Medical device
- ...Procurement operations of our medical products. The position... ...in periodic ISO 13485, FDA, and State of Texas... ...time delivery of high quality, safe products that... ...budget guidelines. Coordinate timely investigations,... ...485 regulated Medical Device Manufacturing and Supply...Medical deviceContract workWork at officeLocal area
Spectral MD
Dallas, TX5 days ago - ...the design, manufacturing, and sales of medical devices (including Class I and II devices,... ...maintaining regulatory approvals, supporting quality management system (QMS) objectives, and... ...requirements. In-depth knowledge of ISO 13485, FDA regulations (including 21 CFR Part...Medical device
- ...of surgical solutions for the medical industry, the Senior... ...subsystems in a regulated medical device environment. Essential Job... ...strategies. Partner with Quality, Operations, Supply Chain, and... ...Ensure compliance with FDA QSR, ISO 13485, ISO 14971, and internal quality...Medical device
Nordson
Parker, TX4 days ago - ...Regulatory Consultant to join our dynamic team in the medical device sector. This role will provide expert guidance on... ...all regulatory requirements, including adherence to quality management standards such as ISO 13485 and FDA QSR. Conduct gap analysis and recommend improvements...Medical deviceFull time
Cedent
Dallas, TX2 days ago $40k - $45k
...users, troubleshoot errors, coordinate RMAs, and document... ...resolutions Assisting the quality assurance group with proper closure... ...complaints, as required by FDA and ISO for medical devices Communicates directly... ...teamwork Familiarity with ISO 13485, FDA, and cGMP, highly...Medical deviceFull timeContract work- ...on technical and application support, quality assurance, product performance and value. We... ...extended periods ~ Familiarity with ISO, AS9100, or other quality standards is... ...Experience in aerospace, defense, or medical device industries Experience working under...Medical deviceAfternoon shift
Amphenol
Parker, TX5 days ago $20 - $25 per hour
...This role serves as the final quality checkpoint in the... ...adherence to IPC-A-610, AS9100D, and ISO standards. The position requires... ...environments such as aerospace and medical devices. Employees can leverage and... ...and growth within quality assurance career paths. Work...Medical deviceWeekly payContract workTemporary workShift workAerotek
Garland, TX3 days ago- ...design control for all products, meeting ISO 13485 requirements. Develop project plans... ...~ Support operations and quality teams in continuous improvement initiatives... ...experience in a manufacturing environment ~ Medical device manufacturing experience including FDA-...Medical deviceWork at office
SWM International
Dallas, TX4 days ago - ...construction problems. ~ Perform quality and compliance inspections. ~... ...facilitate project activities. ~ Coordinates work assignment preparation and completion... ...products. Benefits: ~ Medical, Dental, and Vision Insurance ~...Contract workTemporary workFor contractorsFor subcontractorWork at office
Prism Electric
Garland, TX1 day ago - Company Overview: Argon Medical Devices is a global manufacturer of specialty... ...requirements, including ISO 14155, FDA regulations, EU... ...including Regulatory Affairs, Quality, Medical Affairs, and... ...closeout. Site Management Coordinate site feasibility, selection,...Medical device
$21 - $22 per hour
...Medical Device AssemblerThe Medical Device Assembler works in a fast-paced medical device warehouse... ...according to shipping instructions and quality standards.Work efficiently in a fast-... ...required, such as supporting leads in coordinating tasks or providing guidance to...Medical deviceContract workTemporary workRelocationShift workWeekend workDay shiftAerotek
Dallas, TX3 days ago$70k - $85k
...severe paralysis operate digital devices using only their thoughts—... ...research into real-world medical solutions. As a Precision employee... ...to yield enhancement and quality control efforts. It is an ideal... ...Exposure to quality systems (ISO 13485, FDA QSR / 21 CFR Part 820 /...Medical deviceFull timeInternshipWork at officeRemote work- Job TitleJob Description Required Education: High School Diploma or Equivalent. Required Qualification: Assembly, medical device, use of microscope, quality, inspection, multitasking, teamwork, knowledgeable in relevant computer applications (MS Word and Excel)...Medical device
Rose International
Plano, TX6 hours ago - ...This position ensures product quality and consistency by... ...formulates products in the medical device, OTC, and occasionally cosmetic... ...control for all products, meeting ISO 13485 and internal Scapa procedural... ...team. Must be able to coordinate work with customers, supervisors...Medical device
BioMed Laboratories, LLC
Mesquite, TX5 days ago - Location: Main Hospital Bldg - 1st Flr Primary Purpose Provides engineering services to medical and research areas including selection, acquisition and service of medical devices, project management, clinical/technical problem-solving, device design and solution of...Medical deviceLocal areaRelocation
Parkland Health and Hospital System (PHHS)
Dallas, TX2 days ago - ...HC, LLC is seeking a Vice President of Quality Assurance and Regulatory Affairs to lead quality... ...strategy as the company expands into medical device manufacturing. The role oversees design... ...will align QA/RA with FDA and ISO standards, manage regulator interactions...Medical device
- ...microorganisms. Adhere to Quality Control policies,... ...submission support, consultant coordination, and 510(k) support... ...registrations/device listings, import inspections... ...activities (FDA QMSR, ISO 13485, OSHA). Support... ...years of experience in a medical laboratory and/or medical...Medical deviceFull timeWork at officeShift work
$78k - $156k
...products in diagnostics, medical devices, nutritionals and... ...Title Senior Development Quality Engineer Working at... ...development teams promoting and assuring quality in product... ...in accordance with ISO 14971, FDA QMSR, EU... ...21 CFR Part 820, ISO 13485, ISO 14971, EN 45502-...Medical deviceContract workWork experience placementWorldwideShift workAbbott
Plano, TX2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Assurance Coordinator — Medical Devices (ISO 13485). Be the first to apply!
Related searches