Senior QA Specialist - GMP Medical Device/Regenerative Medicine
Organogenesis
Organogenesis Inc. is seeking a QA Specialist to support new product production and quality review in a regulated environment. You will inspect, release, and validate batches while coordinating cross-functional QA activities with Production, Facilities, Validation, Calibration, Materials, Quality Control, and Logistics. The role emphasizes documentation reviews, batch release, and collaboration with external entities like contractors, suppliers, and customers to ensure regulatory compliance. #J-18808-Ljbffr Organogenesis
$71.7k - $83.2k
About Us We are a leading regenerative medicine company in the advanced and acute wound... ...Organogenesis What You Will Achieve: The QA Specialist performs quality activities in... ...combination 5-8 years of GMP experience in a Medical Device/Biotechnology industry. Demonstrated...Medical deviceTemporary workFor contractorsImmediate startFlexible hours- ...Framingham, MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance and product disposition for BDS, DP, and FDP across internal and external facilities. You will collaborate with QA, QC, Regulatory, and Clinical teams, manage batch release,...Senior
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...Experience in an FDA-regulated environment such as Pharma or Medical Device is preferred.Pay & BenefitsAt Moderna, we believe that when you... ...technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe...SeniorMedical devicePermanent employmentFull timeWork at officeWork from home- Cardinal Health is seeking a Senior R&D Engineer to drive innovative medical products from concept through launch, ensuring compliance with FDA QSR 820, ISO 13485, and GMP. You will lead design control efforts, manage DHF documentation, and collaborate with marketing,...SeniorMedical device
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$109.2k - $174.6k
...biotechnology, pharmaceuticals, life sciences, medical devices, or another regulated industry.• Deep... ...degree preferred.• Experience in a GMP manufacturing environment.• Experience with... ..., the infrastructure to reimagine how medicines are created and delivered, and a world-class...Medical deviceFull timeWork at officeWork from home- ...MA seeks a Principal Associate I/II, Quality Assurance to support GMP compliance for bulk drug substance, drug product and final drug... ...batch release, product complaints, CAPA, change control, deviations, and QA metrics, while mentoring QA #J-18808-Ljbffr Replimune-2Senior
- ...high energy, outgoing individual to join our growing team as Senior Business Development Manager. This role will focus on developing... ...Development/Staffing. Experience working with large pharma, medical device, IT or DOD is preferred. Proven track record of client development...SeniorMedical deviceBase plus commissionContract workWork at officeLocal areaRemote work
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- ...developing transformative gene-based medicines for serious human diseases.... ..., autoimmune, oncology, regenerative medicine and rare diseases.... ....Position SummaryThe Senior Specialist, Site Supply Chain Planning... ...preferred.In-depth knowledge of GMP operations. Demonstrates growing...SeniorFull timeWork at office
- Senior Medical Device Compliance Engineer at SharkNinja in Needham, MA leads design controls and post-market compliance across SharkNinja’s Medical Devices portfolio. The role is hands-on and ensures medical device products are developed and maintained in compliance with...SeniorMedical deviceOverseas
$120k - $130k
...markets. Job Summary: Nova Biomedical is seeking a Senior Software QA Engineer to join the R&D team in Norwood, MA. This newly... ...teams to deliver high-quality software for regulated medical devices. Responsibilities: Develop comprehensive software...SeniorMedical deviceHourly payWork at officeFlexible hours- SharkNinja in Needham, MA is seeking a Senior Medical Device Compliance Engineer to own design controls and post-market sustaining activities across its Medical Devices portfolio. You will ensure global regulatory compliance, lead DHF reviews, risk management, and ECN processes...SeniorMedical deviceOverseas
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$109.2k - $174.6k
...Technical Authority governance model.Ensure compliance with GxP/GMP regulations and Moderna’s quality and documentation systems.Maintain... ...cross-functional technical projects.Exposure to personalized medicine or individualized manufacturing processes (e.g., INT)....SeniorPermanent employmentFull timeWork at officeWork from home- ...to maximize market penetration. What we are looking for in you 2-5 years of experience in product management with systems and medical devices used in hospital core laboratories. Proven experience managing the full product life cycle. Direct experience with hospital core...Medical deviceFull time
- ...Senior GXP Facilities Specialist (Project Management) Job Description: Company Overview... ...transformative gene-based medicines for serious human diseases... ..., autoimmune, oncology, regenerative medicine and rare diseases... ...maintenance competence on GMP utilities and equipment. Proficient...SeniorImmediate start
- ...Company Industry leading developer of medical technology & devices Industry Medical Devices... ...Employees 1001-5000 Categories Medicine Biotechnology Medical... ...instruments collagen orthobiologics regenerative medicine and regenerative...Medical device
$110k - $130k
...biopharmaceutical and clinical markets. Job Summary: The Senior Quality Engineer will be responsible for providing Quality... ...higher in Engineering or the technical sciences ~7 plus years Medical Device/IVD Experience as a Quality Engineer, or 4+ as a Senior...SeniorMedical deviceHourly payWork at officeFlexible hours$109.2k - $174.6k
...Role:Joining Moderna means advancing mRNA science to transform medicine. Work with exceptional global teams on a broad pipeline and build... ...worldwide.This role is embedded within MSAT, supporting external GMP manufacturing across chemical and biologic modalities, including...SeniorPermanent employmentFull timeWork at officeWork from homeWorldwide$103k - $135k
Position SummaryWe are seeking a Senior Application Engineer to provide technical support... ...OEM customers with servo motors, feedback devices, and motion controllers in industries... ...QualificationsExperience in robotics, laboratory automation, medical devices, aerospace, or defense...SeniorMedical deviceFull timeImmediate startFlexible hours- ...Cardiac Device Technician Position: Cardiac Device Technician Department: BMC Health - Cardiovascular Medicine Schedule: Full Time Position Summary Under the supervision... ...Director of Cardiovascular Medicine and the Medical Director the Cardiac Device Technician...Medical deviceFull timeFixed term contractRemote workFlexible hours
- ...1(k) plan for all employees Comprehensive insurance plans for medical, dental and vision coverage for full‑time employees Supplemental... ...plan for all employees Electronic medical records and mobile devices for all clinicians Incentivized bonus plan Responsibilities...Medical deviceFull timeReliefFlexible hours
$92.2k - $141.4k
...do your job hasn’t been invented yet, you’ll fit right in.The Senior Product Safety & Compliance Engineer will have a direct partnership... ...solutions. This role includes active participation in medical device regulatory pathways alongside our consumer and commercial product...SeniorMedical deviceTemporary workLocal areaFlexible hoursShift work$169.58k - $233.18k
...valuing your unique contributions. As a Senior Director, Program Management, you will... ...development programs within a global, regulated medical device environment from program initiation... ..., professionals, and skilled specialists, who believe in each individual’s potential...SeniorMedical deviceTemporary workWork at officeLocal area$130k - $150k
...Instron (a division of ITW) required to drive growth within the medical device and pharmaceutical industries and ensures that the Instron has... ...device or pharmaceutical industry and familiarity with GMP requirements. Must have a passion for technology and innovation...Medical deviceWork at officeLocal areaFlexible hours$145k - $170k
...globally Our Opportunity We are currently seeking a Senior Associate for our Thermal Sciences Practice in Natick MA. In... ...utilities, fire and explosion investigation, power generation, medical devices, and many others. Specific duties will include conducting, planning...SeniorMedical deviceWork at officeFlexible hours
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