Quality Team Lead - Medical Devices (ISO 13485/FDA)
Viant Medical
Viant Medical is seeking a Quality Supervisor to oversee quality management within our Indianapolis facility. The role requires maintaining compliance with ISO standards and effective leadership in a manufacturing inspection environment. You will manage Quality Inspector associates and ensure adherence to safety and quality regulations, while also overseeing inspection activities to maintain product quality. This position offers various benefits including medical, dental, and vision coverage, generous PTO, and a supportive work environment. #J-18808-Ljbffr Viant Medical
- ...is seeking a Manufacturing Quality Assurance (QA) Supervisor located... .... Responsibilities include leading audits, investigating... ...and ensuring compliance with ISO 9001 and ISO 13485. The ideal candidate will manage... ...with cross-functional teams. Benefits include comprehensive...QualityFull time
$50k - $60k
...Legacy Group in Indianapolis is looking for a Quality Assurance (QA) Supervisor to oversee the Quality Management System aligned with ISO standards. The role includes managing QA... ...0-$60K and full benefits. Join a dedicated team committed to continuous improvement and customer...Quality- ...Indianapolis, Indiana, is looking for a Quality Assurance Specialist to... ...involves managing customer complaints, leading the internal audit program, and... ...or equivalent experience in medical device manufacturing and knowledge of ISO 13485 are required. Proficiency in Microsoft...QualityMedical deviceWork at office
- ...Corporation is a dedicated team of owner-... ..., meticulous device assembly, and value... ...services. Certified to ISO 13485:2016 standards, FDA Registered, and... ..., including medical devices, RF/Microwave... ...delivering high-quality assemblies that... ...-site role for a Lead Machinist at our...QualityMedical deviceFull time
$150 per hour
...customers to provide the highest quality, life enhancing medical devices in the world. Work Schedule 7:00am... ...Systems (QMS) in accordance with ISO 13485 and FDA 21 CFR 820 requirements as well as... ...environment and self-directed work team through open communication, trust...QualityMedical deviceLocal areaWorldwideShift work- ...Overview The Lead Enterprise Architect... ...and the various Medical Informatics... ...skills within project teams and externally with... ...to the Company's quality and regulatory... ...Administration (U.S. FDA) medical device regulatory... ...requirements, applicable ISO 13485 standard...QualityMedical deviceWork experience placementLocal areaRemote workFlexible hours
- Avalign Technologies is seeking a Sr. Quality Engineer in Greenwood, Indiana. The ideal candidate... ...compliance with industry standards such as FDA Quality System Regulation and ISO 13485. Competitive benefits and a supportive team environment await for those ready to thrive...QualityMedical device
$80k - $100k
...Job Title: Quality Engineer Industry: Medical Device Manufacturing Responsibilities:... ...with industry standards - ISO 13485 and FDA regulations. Develop... ...audits with the quality team, preparing reports and... ...progressive quality experience leading to engineering ~...QualityMedical device$95k - $105k
A manufacturing client in Indianapolis seeks a Quality Engineer for a direct hire position. The role involves improving quality results and leading continuous improvement efforts in a facility that values innovation. Key requirements include a Bachelor's degree in Engineering...Quality- ...Olson Custom Designs is an AS9100D and ISO 13485 certified contract manufacturer... ...precision CNC machining for aerospace and medical device industries. We are ITAR registered and... ...machining processes Collaborate with quality team to ensure programs meet stringent AS91...QualityMedical deviceContract work
$50k - $60k
Southern Indiana, Inc. is seeking a Manufacturing Quality Assurance (QA) Supervisor in Indianapolis, IN. This full-time leadership... ...Quality Management System (QMS) to ensure compliance with ISO 9001 and ISO 13485 standards. Responsibilities include managing internal audits...QualityFull time- ...throughout the Defense, Aerospace, Medical Devices, and Commercial market... ...or storage. Adhere to Quality Management System... ...defective parts and work with team members to identify root cause... ...manufacturing and quality systems (ISO 9001:2015, ISO 13485, and AS9100D). ~...QualityMedical device
- ...6DescriptionA growing medical device company specializing in... ..., the consultant will lead efforts to transition... ...assessments for capacity, quality systems, and... ...lean manufacturing, SPC, ISO 13485, FDA/CE regulatory landscapesAdvanced... ...diverse and inclusive team from a variety of...QualityMedical deviceLocal area
- ...Quality Technician GTC Machining has grown from a very humble... ...the Defense, Aerospace, Medical Devices, and Commercial market segments... ...experience preferred (ISO 9001:2015, ISO 13485, and AS9100D preferred)... ...Microsoft Office Suite Team player who enjoys challenging...QualityMedical deviceContract workWork at office
- ...Defense, Aerospace, Medical Devices, and Commercial market... ...NPI) efforts and drive quality improvements. Provide... ...cross-functional teams to ensure effective information... .... Ability to lead CNC programming... ...experience preferred (ISO 9001:2015, ISO 13485, and AS9100D preferred...QualityMedical device
- ...unsolicited resumes.***About the Automation Technical Team Lead**We take pride as a contract medical device manufacturer solving problems and partnering with... ...automation strategies align with production needs, quality requirements, and business objectives within a regulated...QualityMedical deviceContract workTemporary workLocal areaVisa sponsorshipShift work
- ...Validation) Engineer Medical Device Contract Manufacturer... ...is responsible for leading and supporting process... ...maintained in compliance with FDA Quality System Regulation (21 CFR Part 820), ISO 13485, customer... ...Supply Chain, and customer teams to ensure successful project...QualityMedical deviceFull timeContract workFlexible hours
- ...functional testing and quality assurance, and the fulfillment... ...per Fujifilm Medical Informatics Design Control... ...Destructive Testing (NDT) team harnesses advanced... ...Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements...QualityMedical deviceFor contractorsWork experience placementWork at officeLocal areaRemote workFlexible hours
- ...throughout the Defense, Aerospace, Medical Devices, and Commercial market... ...Description Reports to: Quality and Safety Manager Job... ...and report to the quality lead Develop, maintain, and generate... ...experience preferred (ISO 9001:2015, ISO 13485, and AS9100D preferred)...QualityMedical deviceWork experience placement
- ...Benefits: Kimball Medical Solutions provides 3 weeks... ...meeting goals of quality, cost and delivery for... ...of a growing Medical Device contract manufacturer... ...and as a member of a team The ability to work... ...requirements contained in ISO-13485, and FDA CFR/GMP Medical Device...QualityMedical deviceContract workTemporary workLocal areaVisa sponsorshipAfternoon shift
- ...Quality Associate The Quality Associate supports the... ...activities comply with GxP, FDA, and quality system requirements for medical device and pharmaceutical... ...Chain, and Manufacturing teams to establish compliant processes... ...GxP, FDA, and ISO requirements Partner...QualityMedical deviceRemote work
- Goodwill of Central & Southern Indiana is seeking a Quality Assurance Supervisor located in Indianapolis. This role focuses on overseeing the Quality Management System, ensuring compliance with ISO standards, and providing leadership to QA personnel. The position entails...Quality
- ...and cost-effective medical devices with a particular focus... ...and ingenuity. Our team is growing quickly... ...our customer’s quality specifications for... ...corrective action plans. Lead in implementation... ..., including FDA Quality System Regulation and ISO 13485. Supports operations...QualityMedical device
$43.27 - $48.55 per hour
...Destructive Testing (NDT) team harnesses advanced... ...the products. Approves FDA-2579 submissions for MG... ...all safety practices and quality procedures. Promotes... ...Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and...QualityMedical deviceHourly payOdd jobWork at officeLocal areaRemote workFlexible hours$105.4k - $195.8k
...embraced for the unique qualities you bring. Our... ...in the USA.**Your New Team**As Manufacturing Science... ..., and Rotkreuz, we lead technology strategy,... ...for the assembly of medical devices. Your focus is on industrialization... ...(e.g., GMP, ISO 13485, MDR, FDA) and support for the...QualityMedical deviceLocal areaRelocation package$89.6k - $157k
...staying connected with your team. We ask that you join your... ...and Key responsibilities Lead and coach the... ...methodologies to improve efficiency, quality, and consistency. Oversee... ...management-level support for ISO 13485 and Software as a Medical Device regulatory process,...QualityMedical deviceWork at officeRemote work- ...components used in life-enhancing medical devices, in a modern, clean, and... ...safety-first environment Team-Oriented Culture: Skilled... ...professionals who take pride in quality work Stability & Growth:... ...Blueprint Reading & GD&T ISO 13485 FDA 21 CFR 820 CAD/CAM...QualityMedical deviceWork at officeRelocationRelocation packageShift workWeekend workDay shiftAfternoon shift
$65.25k - $169.4k
...around the world. Quality Assurance professional... ...supporting medical device and combination product... ...mitigated, and validated. Lead and support... ...and mentor junior QA team members and influence... ..., including: FDA: 21 CFR Parts 4, 11, 210/211, 820 ISO 13485, ISO 14971 EU MDR,...QualityMedical deviceFull timeContract workH1bWork at officeVisa sponsorshipWork visaFlexible hours$74.68k - $88.8k
...for sales and company team members with respect to... ...compliance with the company's quality procedures. Assist with... ...of the FUJIFILM Medical Systems solution. Participates... ...Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements...QualityMedical deviceWork at officeLocal areaRemote workLong distanceFlexible hours- ...our Non-Destructive Testing (NDT) team harnesses advanced radiography... ...systems. Adheres to the Company's quality and regulatory compliance... ...Food and Drug Administration (U.S. FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements and all...QualityMedical deviceLocal areaRemote workFlexible hoursNight shiftWeekend work
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