Medical Device Quality Engineer (GMP/ISO)
Enovis
Enovis in Austin, TX is seeking a Medical Device Quality Engineer to join the Quality Assurance team. You will shape QA procedures, validate processes, and ensure compliance with GMP/ISO standards, supporting manufacturing and serving on the Material Review Board. The ideal candidate holds a science or engineering degree with 3–5 years in regulated environments, with hands-on experience in IQ/OQ/PQ, metrology and device quality issues, and proficiency in SolidWorks and ERP tools. #J-18808-Ljbffr Enovis
- ...ENOV) is an innovation-driven medical technology growth company... ...As a key member of the Quality Team you will play an integral... .... Job Title: Medical Device Quality Engineer Reports To: Sr Manager... ...and standards (i.e. GMP, ISO, FDA, CMDR). Reviewing trends...SuggestedFull timeH1bWork at office
- ...innovation-driven medical technology growth company... ...key member of the Quality Assurance team you... ...Quality Assurance Engineer – Design Quality... ...design quality in ISO and FDA audits Authoring... ...standards (i.e. GMP, ISO, FDA, MDD) Reviewing trends in device failures associated...SuggestedFull timeWork at office
- Katalyst CRO is seeking a Quality/Regulatory Compliance professional to ensure QMS alignment with FDA 21 CFR Part 820, ISO 13485, EU MDR, and related standards. The role focuses... ...ensuring regulatory conformance for medical devices including SaMD and class II devices. Strong...SuggestedLocal area
- Neuralink is seeking a Software Design Controls Engineer to own the software life cycle strategy for implantable electronics and related... ...You will ensure robust design control practices across IEC 62304, ISO 14971, and ISO 13485, collaborating with software and firmware...Suggested
- Role Quality Engineer I supporting new product development and existing product line manufacturing within a medical device company specializing in cardiac and vascular devices... ...industry knowledge of GMP, Quality System Regulations, and ISO standards. Additional Information...Suggested
- ..., control systems, and related support equipment while ensuring quality and process reliability. Responsibilities include setup/breakdown... ...documentation. Candidates should have manufacturing experience, GMP knowledge, and strong English communication in a regulated...
$116k - $159.5k
...leader in materials science and engineering solutions that are at the... ...Overview The Manufacturing Test Quality Engineer bridges high-... ...cleanroom contamination regulations (ISO Class 4 / Class 100 protocols... ...manufacturing, complex medical equipment manufacturing, or high...Permanent employmentFull timeShift work- Artivion, Inc. in Austin, TX, seeks a Quality Engineer I to join our On-X Heart Valve team. You will apply quality engineering methods to support new product development and ensure compliance with federal, industry, and corporate standards. The ideal candidate has a bachelor...
- Scorpion Therapeutics is hiring a Quality Engineer I to support new product development and the existing product line manufacturing within a medical device company focused on cardiac and vascular devices. Responsibilities include technical quality support, analyzing non...
- Artivion, Inc. in Austin, TX, seeks a Quality Engineer I to support new product development and existing product lines with Quality Engineering and Quality Assurance techniques. You will analyze non-conformances, lead CAPA activities, validate equipment, processes, and...
- ...ensuring compliance with FDA/ISO 13485 and alignment with... ...ensuring design integrity, quality, and manufacturability. Investigate... ..., alternative solutions to engineering and production challenges... ...outcomes. Interpret and apply medical device regulations and standards to...Remote work
- ...effective implementation of the Quality Management System (QMS). The... ...compliance with applicable medical device regulations and standards,... ...FDA 21 CFR Part 820, ISO 13485, IEC 62304 and EU MDR... ...required. Bachelor's degree in Engineering preferred. Technical, engineering...Work at officeLocal area
- ...Remote Job description: This position utilizes Quality Engineering and Quality Assurance techniques to support new... ...industry (pharmaceutical, biomedical, or medical device), with strong knowledge of GMPs, QSR, and ISO standards main focus will be to perform validations...Work experience placementRemote work
- ...specializes in developing innovative medical devices aimed at addressing challenging cardiac... ...Valve, click here.Position Objective:The Quality Engineer I utilizes Quality Engineering and... ...Practices, Quality System Regulations, and ISO Standards.Benefits:Comprehensive...Full time
- ...including HPLC and GC working knowledge of ISO 9001, ISO/IEC 17025, ISO 17034 standards Preferred experience in GLP/GMP or ISO-regulated settings familiarity... ...(UV-Vis, RI, ELSD, FID) knowledge of quality systems in pharma or medical device sectors High-value expertise in...
- ...safety enhancements, life-saving medical devices, consumer electronics and... ...intellectual property security and quality manufacturing services. Step... ...a Staff Quality Assurance Engineer with strong semiconductor... ...of the following standards: ISO 9001, IATF 16949, ISO 13485,...Temporary work
- ...safety enhancements, life-saving medical devices, consumer electronics and... ...intellectual property security and quality manufacturing services. Step... ...Customer Quality Assurance Engineer to join our dynamic team to... ...systems and standards: ISO 9001 and IATF 16949. Participate...Permanent employmentTemporary workWork at office
$103k - $191k
About Neuralink:We are creating devices that enable a bi-directional... ...and Responsibilities:The Quality Engineer, Software Design Controls will... ...for design changes within the medical device design control process... ...in accordance with IEC 62304, ISO 14971, ISO 13485, and related...Full timeTemporary work$103k - $191k
...Neuralink:We are creating devices that enable a bi-... ...Responsibilities:The EMC Compliance Engineer will own EMC compliance... ..., manufacturing, quality, and regulatory teams... ...changes within the medical device design control process... ...familiarity with ISO/IEC 17025 requirements,...Full timeTemporary work- Confluent Medical Technologiesis dedicated to working collaboratively... ...world-class medical devices through innovative material science, engineering and manufacturing. Our... .... We’re looking for a Quality Engineer, Senior Staff... ...experience with FDA, ISO 13485 and EU MDR Design...Work at officeLocal areaVisa sponsorshipWork visa
$55 - $60 per hour
...Requirements: B.S. in Electrical Engineering or related field. 3 years of... ...: Our Benefits Include: Medical, Dental, and Vision Insurance... ...organization is certified to ISO 9001, ISO 14001, ISO 27001, and... ...reflecting our commitment to quality, security, operational excellence...Temporary workLocal area$33 - $36 per hour
...Title: Engineer - Degreed II Location: Austin TX (100% Onsite) Duration: 9 Months... ...Support day-to-day Quality Operations in a medical device manufacturing environment Act as Customer... ...cause analysis Ensure adherence to GMP, FDA, ISO 13485, and QMS requirements Review...Work experience placementShift work- ...career.THE ROLE: We are seeking a motivated Quality Engineer to join our team and support the... ...Support the implementation and maintenance of ISO 9001 and IATF 16949 standards. Ensure... ...to age, ancestry, color, marital status, medical condition, mental or physical disability...
- ...the extraordinary.Job SummarySummary:The “Quality Engineer” will be based in Austin Research Blvd,... ....Apply fundamental ASME Y14.5 and/or ISO GPS principles to interpret, evaluate, and... ...the great work you provide:Full range of medical, dental, and vision plansLife...Full timeVisa sponsorshipFlexible hours
- ...extraordinary.Job Summary Summary: The “Supplier Quality Engineer” will be based in ……., reporting to ……... ...Organization for Standards (ISO) and regulatory standards. Forms a good... ...the great work you provide:Full range of medical, dental, and vision plansLife InsuranceShort...Full timeVisa sponsorshipFlexible hours
- ...verify conformance to specifications and quality requirements. Utilize precision measurement... ...and visual inspections. Review engineering drawings, specifications, and Geometric Dimensioning... ...of FDA Quality System Regulations, ISO 13485 requirements, and other applicable...Work at office
$115k - $136k
Austin, TXQuality - Quality Assurance /Full-time /On-sitePlease Note: To conform with the... ...looking to add a Senior Supplier Quality Engineer to our team. If you enjoy working in a startup... ...management systems such as AS9100 or ISO 9001.Expertise in root cause analysis methodologies...Permanent employmentFull timeContract workWork experience placementLocal area- ...TechniciansValidation & Engineering Group, Inc. (V&EG) a... ..., Chemical, Food, and Medical Devices industries in the following... ...following strict quality and safety procedures.... ...quality systems, including ISO 13485 and FDA 21 CFR... ....Familiarity with GMP, GDP, ISO 13485, FDA regulations...
- ...specializes in developing innovative medical devices aimed at addressing... ...Responsible for operating the Quality Management System (QMS). To... ...of experience in quality engineering, quality assurance, or a similar... ...System Regulations, and ISO Standards. Benefits Comprehensive...Work experience placement
- ...lifecycle management for clients across pharma, medical devices, biotech, and food industries. The role involves... ...regulatory changes, ensuring programs meet FDA/EMA/ISO/GMP standards, and collaborating with R&D, Quality, and Manufacturing teams to gather data for submissions...
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