QA Inspector I - Medical Devices (FDA/ISO)
INTEGRA LIFESCIENCES CORP
INTEGRA LIFESCIENCES CORP in Plainsboro Township is looking for a Quality Inspector I responsible for performing quality assurance inspections on purchased components and final products following corporate policies and regulations. The ideal candidate will have a high school diploma, QA experience in the medical device industry, and strong attention to detail. Benefits include medical, dental, vision insurance, and a 401(k) savings plan. #J-18808-Ljbffr INTEGRA LIFESCIENCES CORP
$19.19 - $25.43 per hour
...Quality Inspector IJoining us is a chance to do important work that creates change and shapes the future of healthcare... ...the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory...Medical deviceDay shift- ...Corporation is looking for a Quality Inspector I in Plainsboro Township, NJ. This... ...and products, following FDA regulations and ISO standards. The ideal candidate will... ...High School Diploma, experience in QA within the medical device sector, strong organizational and...Medical deviceWork at office
$26.21 - $35.38 per hour
...outcomes and set new standards of care.The Lead Quality Inspector serves as a Lead Associate, Quality Inspector for... ...the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory...Medical deviceTemporary workWork at officeShift workWeekend work$26.21 - $35.38 per hour
Position Lead Quality Inspector - Weekend Lead (12‑hour shift, Friday‑Sunday 6:00a.m.-6:30... ...Regulatory Compliance environment, preferably in medical device, diagnostics or pharmaceutical industries. Familiarity with FDA regulations and ISO 9001/13485 and other applicable quality...Medical deviceHourly payTemporary workWork at officeShift workWeekend work- ...audits, maintain supplier quality requirements, and provide QA leadership to contract manufacturers and raw material suppliers... ..., CAPA, change control, supplier quality agreements, and ensuring compliance with FDA CFR 820 and ISO #J-18808-Ljbffr Integra LifeSciencesMedical deviceContract work3 days per week
- ...Essenlix Corporation is a fast-growing medical device company focused on developing innovative... ...overseas manufacturing facility in China is ISO 13485 certified. We are strengthening our... ...to commercialization in preparation for FDA clearance and international market expansion...Medical deviceOverseas
- ...used” Must be able to understand and follow cGMP; QSR, USP and ISO Perform additional production support tasks as assigned... ...related science a plus. 1 to 2 years of cleanroom experience in the Medical Device or Pharmaceutical/Biotech industry Basic computer skills for email...Medical deviceImmediate startFlexible hoursRotating shift
- ..., contamination control, and regulatory compliance. The role requires extensive experience with sterilization of medical devices and strong knowledge of ISO standards. This position involves collaboration with Product Development, Regulatory Affairs, and Quality teams,...Medical device
$26.21 - $35.38 per hour
...INTEGRA LIFESCIENCES CORP is searching for a Lead Quality Inspector for a weekend lead position. Responsibilities include overseeing... ...over 5 years of experience in quality systems, particularly in medical devices, and familiarity with relevant regulations. This role offers...Medical deviceHourly payWeekend work- ...Expanding Operations for a Medical Device ManufacturerA large medical device manufacturer needed to expand their plant production from 55 million units per year to 85 million units per year. To meet this aggressive goal, they needed to hire 60 skilled automation technicians...Medical device
$71.3k - $97.75k
...manufacturing processes. The role involves cross-functional collaboration to enhance workflow and efficiency while ensuring compliance with FDA regulations and other industry standards. Qualified candidates should possess a Bachelor’s degree in engineering, 2-6 years of...Medical device- ...documentation compliance Meeting requirements for U.S. and International requirements as defined in FDA Regulations, ISO 9001 Standards, ISO 13485:2016, Medical Device Directives, Canadian Medical Device Regulations and other International Regulations.Bachelor's degree...Medical deviceNight shift
$149.7k - $213.2k
...leadership and technical expertise in the development of regulated medical device and homeopathic products, including design, formulation,... ...regulations and quality systems (e.g., Design Controls, ISO 13485, FDA/cGMP), including proper development documentation (e.g., Design...Medical deviceFull timeRemote workMonday to Friday$47.1 - $52.1 per hour
...to 5+ years of experience in a Quality Assurance role for medical device or pharmaceutical manufacturing.Demonstrates knowledge of... ...regulations and guidelines: U.S. Food and Drug Administration (FDA) regulations, ISO 9001, ISO 13485, Medical Device Directive (MDD), the...Medical device- ...are a global leader in medical imaging, offering an extensive... ..., medical devices, digital and AI solutions... ...for a qualified, dynamic QA Manager to enhance our quality... ...ensuring compliance with FDA regulations including CFR... ...Federal Regulations), ISO standards, industry best...Medical deviceFor contractorsLocal area
- ...Essenlix Corporation: Essenlix Corporation is a fast-growing medical device company focused on developing innovative point-of-care (POC)... ...worldwide. Our overseas manufacturing facility in China is ISO 13485 certified. We are strengthening our U.S.-based development...Medical deviceWorldwideOverseas
- ...About the Company Industry leading developer of medical technology & devices Industry Medical Devices Type Public Company... ...compliance with a range of regulatory standards, including FDA regulations, ISO 13485, and various international medical device...Medical device
$192.05k - $263.35k
...ReadinessEnsure supplier and contract manufacturer compliance with FDA, ISO 13485, EU MDR, MDSAP, and other global regulatory... ...discipline.15+ years of progressive experience in Quality within the medical device or regulated life sciences industry, including significant...Medical deviceFull timeContract workTemporary work$86.7k - $173.3k
...businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines... ...and validations in accordance with FDA QSR’s and specific Design Control projects... ...measuring equipment. Working knowledge of GMP, ISO standards, FDA regulations, and Health...Medical deviceWorldwide- ...of experience in a Validation or Quality Assurance role for a medical device or pharmaceutical environment. ~ Experience using temperature... ...compliance with cGMP, cGLP, QSR (including Design Controls), ISO or other applicable requirements. • Support and address...Medical deviceRemote work
- ...the global life sciences industry across clinical development, medical affairs, regulatory, pharmacovigilance, quality and commercialization... ...and clinical research expertise, we help biopharma and medical device companies accelerate innovation, improve compliance, navigate...Medical devicePermanent employmentFull timeRemote work
$166.75k - $228.85k
...microbiology SME in internal audits, and external audits such as FDA inspections, ISO certifications, surveillance audits and customer audits.... ...ST72, ISO 11737, ISO 14644, ISO 14698, ISO 22442, CMDR, Medical Device Directive, and USP.DESIRED MINIMUM QUALIFICATIONSThe...Medical deviceFull timeTemporary work$166.75k - $228.85k
...regulatory readiness, and enterprise risk management across the medical device lifecycle. The Director, Quality Program Management,... ...Quality.Ensure analytics outputs meet regulatory requirements (FDA QSR/QMSR, ISO 13485, EU MDR, and MDSAP, at minimum).Serve as a key leader...Medical deviceFull timeTemporary work- ...multiple facilities. The role demands extensive GMP auditing experience and the ability to evaluate quality management systems within medical device environments.The ideal candidate will report site audit findings, recommend improvements, and support inspection readiness...Medical device
$225.4k - $316.25k
...development, manufacture, and distribution of medical devices in compliance with corporate policies, U.... ...and Drug Administration regulations, ISO 13485, the Canadian Medical Device... ...appropriate regulations and standards, including FDA Part 820, ISO 13485, CMDR, MDR, MDSAP,...Medical deviceFull timeTemporary workWork experience placement$109.25k - $149.5k
...Marketing, Manufacturing Facilities and Medical Affairs.ESSENTIAL DUTIES AND... ...studies as deemed necessary.Participate in FDA inspections, ISO Certification and surveillance audits,... ...engineering or R&D Engineering for medical device, with at least 3 years of direct DQA experience...Medical deviceFull timeTemporary work- ...used" • Must be able to understand and follow cGMP; QSR, USP and ISO • Perform additional production support tasks as assigned... ...science a plus. • 1 to 2 years of cleanroom experience in the Medical Device or Pharmaceutical/Biotech industry • Basic computer skills for...Medical deviceImmediate startFlexible hoursShift workRotating shift
$109.25k - $149.5k
...diverse portfolio of leading medical devices. Ensure that the corporate audit... ...in compliance with recognized ISO, GMP, GDP, GCP, and GLP,... ...education and work experience in QS/QA/QC/OPS or a technical... ...regulatory agencies (such as U.S. FDA, MHRA, TGA, Health Canada, SFDA...Medical deviceFull timeTemporary workWork experience placement$109.25k - $149.5k
...compliance with all appropriate regulations and standards, including FDA, ISO 13485, CMDR, MDR, 21 CFR Part 11 & IQ/OQ/PQ. Interact and... ...and component qualification - IQ/OQ/PQ and data analytics. Medical Device or Pharmaceutical experience is required. Experience or...Medical deviceTemporary work- ...Inspection procedures and assigned by the Lead Inspector. Follow all work instruction related to... .... Document inspection results in QA log book. Communicate non-conforming product... ...is Illegal Poster. If, because of a medical condition or disability, you need a reasonable...Hourly payFull timeTemporary workFlexible hoursShift work
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