Quality Engineer - Medical Device | ISO 13485 & CAPA
Flextronics - The Flex Company
A leading manufacturing company located in Austin, TX is seeking a Quality Engineer to maintain quality engineering standards and programs. You will develop inspection and testing methods, handle quality data, and ensure compliance with regulatory standards. The role requires a bachelor's degree in engineering and 2+ years of quality experience, ideally in the medical device or pharma industry. A full range of benefits, including medical and 401(k), is offered. #J-18808-Ljbffr Flextronics - The Flex Company
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Quality Engineer - Medical Device | ISO 13485 & CAPA in Austin, TX vacancy
- Cedarparktexasedc in Austin, Texas, is seeking a quality assurance (QA) engineer to support new product development. This role involves ensuring compliance with ISO and FDA standards, conducting audits, and authoring quality procedures. Candidates should have a Bachelor...Suggested
$97.9k - $127.4k
...Required (Mechanical or Industrial Engineering) Industry: Medical Device Manufacturing Apply: Directly through... ...components — ensuring efficiency, quality, regulatory compliance, and long-... ...teams Ensure compliance with FDA, ISO 13485, ISO 9001, and GMP standards ---Machines...SuggestedFull timeMonday to FridayFlexible hoursShift workDay shiftKARL STORZ
Austin, TX19 hours ago$97k - $121k
...seeking a highly skilled Software as Medical Device (SaMD) Quality Engineer with substantial experience in SaMD... ...Clinical teams to ensure compliance with ISO 13485, 21 CFR Part 820, IEC 62304, ISO 14... ...issues, nonconformances, and CAPAs using root cause analysis techniques...SuggestedTemporary workFlexible hoursSenseye
Austin, TX1 day ago$45 per hour
Hire Up Staffing Services is looking for a Quality Assurance Engineer in Austin, Texas. This role emphasizes ensuring product quality and regulatory compliance while supporting both new product development and existing product improvements. The ideal candidate will have...Suggested- Frey Consulting Group is seeking a detail-oriented Quality Assurance Engineer in Austin, Texas. The role involves improving quality systems, supporting... ...manufacturing. Ideal candidates have experience with ISO 9001, GD&T, root cause analysis, and strong communication skills...Suggested
- ...notified body audit. Evaluate the medical device manufacturer's Quality Management System (QMS) against ISO 13485:2016 and EU MDR 2017/745,... ..., Validation) CAPA, Complaint Handling, and Post... ...: Bachelor's degree in Engineering, Life Sciences, or a related...Immediate start
Katalyst Healthcares and Life Sciences
Austin, TX17 hours ago - ...Senior Quality Assurance Engineer Bold Thinking. World Changing. At SkyWater, our ingenuity... ...enhancements, life-saving medical devices, consumer electronics and American... ...more of the following standards: ISO 9001, IATF 16949, ISO 13485, AS9100 Familiar with Automotive...Temporary workWork experience placement
SkyWater Technology
Austin, TX4 days ago - A medical technology company in Austin is seeking a Quality Control Inspector to join their team. The role involves performing inspections, ensuring compliance with FDA and ISO regulations, and working collaboratively with cross-functional teams. Candidates should possess...
$45 per hour
Hire Up Staffing is seeking a Quality Assurance Engineer to support our client in... ...corrective and preventive actions (CAPA) Monitor product quality... ...highly regulated industry (medical device, aerospace, automotive, etc... ...Preferred Knowledge of ISO quality standards and...Work at officeMonday to Friday- ...Job Overview The Supplier Quality Engineer is responsible for ensuring... ...corrective and preventive actions (CAPA) in collaboration with... ...company quality standards (ISO, TS16949, etc.). Continuous... ...automotive, defense, aerospace, medical devices, etc.). Physical Demands...Temporary workWork experience placementWork at office
$71k - $119k
Neuralink is seeking a Regulatory Engineer to manage regulatory affairs and collaborate with R&D teams in Austin, Texas. The role involves preparing regulatory submissions and ensuring compliance with global standards. The ideal candidate holds a Bachelor’s Degree in Engineering...$83.3k - $111.1k
...development lifecycle as a quality core team lead for New Product... ...~ Bachelor’s degree in Engineering or Science field (Chemistry,... ...regulated industry (pharmaceutical, medical device, or biotech) preferred ~... ...Strong knowledge of cGMP, ISO 13485/14971, IEC 62366, EU IVDR,...Temporary workRelocation packageThermo Fisher Scientific
Austin, TX8 days ago- ...protecting our planet. We're hiring a Quality Engineer to own quality across our supply chain... ...drive corrective and preventive actions (CAPA) to closure Manage the non-conformance... ...comparators, etc.) ~ Familiarity with ISO 9001 and the fundamentals of building or...RelocationRelocation package
Exowatt
Austin, TX11 hours ago - ...solutions. About the Role: The Sr. Quality Engineer will drive quality and compliance initiatives... ...corrective and preventive actions (CAPA). Oversee product inspections, testing... ...compliance. Manage and maintain all global ISO certifications (9001, 14001, 27001, 4500...Local areaWorldwideFlexible hours
AVIAT US INC
Austin, TX1 day ago - Now Hiring: Quality Systems Specialist (Medical Devices) Client Industry: Orthopedic Medical Devices... ...of: FDA 21 CFR Part 820 ISO 13485 EU MDR ISO 14971 Hands-... ...: Design Controls CAPA Nonconformance Management... ...plus. Bachelor’s degree in Engineering or related technical field...Contract workLocal areaImmediate start
- A leading medical devices company based in Austin, Texas, is seeking a Process Engineer to provide engineering support for manufacturing processes. The role involves improving efficiency, ensuring adherence to operating procedures, and collaborating on new product launches...
- On-X Life Technologies, Inc. is looking for a Process Engineer based in Austin, Texas. This role involves providing engineering support... ...possess 2-5 years of related experience, ideally within the medical device industry. The company offers comprehensive benefits including...
$93.68k - $140.52k
...manufacturing, and sales of medical devices (including Class I and II devices... ...approvals, supporting quality management system (QMS) objectives... ...and preventive action (CAPA) efforts as assigned. providing... ...requirements. In-depth knowledge of ISO 13485, FDA regulations (including...Contract work- Zimmer Biomet in Austin, Texas is seeking an experienced Engineer to drive product functional requirements and testing strategies in the medical device sector. Your role will involve designing and integrating components, identifying issues, and meeting performance targets...
- Zimmer GmbH is seeking a Senior Mechanical Engineer for Monogram in Austin, Texas. The role focuses on developing surgeon-guided robotic... ...possess a Bachelor's degree in Engineering, experience in medical devices, and proficiency in tools like Solidworks. Join a dynamic...
- Intuitive is seeking a Field Service Engineer 2 in Austin, Texas, to support, troubleshoot, and maintain their products. The ideal candidate will have expertise in electro-mechanical systems and exceptional customer service skills. Responsibilities include providing technical...
- A medical technology company based in Austin, Texas, is seeking a Microelectronics Process Engineer to own backend microfabrication processes. The ideal candidate should have over... ...cross-functional teams, and ensuring device quality. A bachelor's degree in Electrical...
- ...Position Summary The Senior Quality Engineer is responsible for driving quality... ...Ensure compliance with ISO 9001, S-A-01, industry regulations... ...plans, FMEAs, PPAPs, SPC, CAPA, NCRs). Collaborate with Supplier... ...with employer contributions; medical, dental and vision insurance;...Temporary workWork experience placementWorldwideFlexible hours
- A medical technology company in Austin, Texas is looking for a Process Engineering Manager to lead a team for new product introduction. This role involves designing new manufacturing... ...experience, preferably in medical device manufacturing. This position offers a comprehensive...
- A leading medical technology company is seeking a Supplier Development Engineer in Austin, Texas. The role requires a bachelor's degree and at least 5 years of experience... ...involves collaborating across teams to ensure quality in supply chains and resolve technical issues....
- ...specializes in developing innovative medical devices aimed at addressing... ...requested from users. Work with quality to maintain user accounts for... ...related to training (NC/CAPA) and implementation of training... .... Working knowledge of ISO 13485 and other regulations/standards...Work experience placement
CryoLife
Austin, TX3 days ago - ...ensure compliance with FDA and ISO 13485 requirements. Partner cross-functionally with Quality, Regulatory, Supply Chain,... ...Requirements: Bachelor's degree in engineering, science, or related... ...of 4 years of experience in medical device manufacturing or other regulated...
Katalyst HealthCares & Life Sciences
Austin, TX18 hours ago - ...Scope The Sr. Quality Assurance... ...reviewing and verifying Device History Records... ...Part 820), and ISO standards (e.g., ISO 13485). This role... ...materials and finished medical devices and... ...investigations (e.g., CAPA, NCs) related to... ...life science or engineering or equivalent...Ongoing contractWork at officeLocal areaWorldwide
DiaSorin
Austin, TX1 day ago - ...innovation-driven medical technology growth... ...experienced medical devices regulatory affairs... ...,EU MDRISO 13485, ISO 14971,21 CFR820and company-wide quality standards. Working... ...regulatory-related CAPAs, driving root cause... ...in the review of engineering specifications and...Full timeH1bLocal area
Enovis
Austin, TX5 days ago - ePac Holdings, LLC in Austin is seeking a Quality Control Manager to lead the development... ...have a Bachelor’s degree in Science or Engineering and 3-5 years of Quality Assurance experience... ...and comprehensive benefits including medical, dental, and 401(k). #J-18808-Ljbffr...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Engineer - Medical Device | ISO 13485 & CAPA. Be the first to apply!
Related searches
- program quality engineer Austin, TX
- quality engineer- qms Austin, TX
- advanced quality engineer Austin, TX
- senior quality systems engineer Austin, TX
- quality engineer remote Austin, TX
- customer quality engineer Austin, TX
- quality systems engineer Austin, TX
- senior supplier quality engineer Austin, TX
- supplier quality engineer Austin, TX
- senior data quality engineer Austin, TX