2mo
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Staff Engineer, Design Quality (CDx/FDA)
Marlborough, Massachusetts, United States
$105k-$125k/yr HybridFull Time
8+ YOESenior design quality expert with 8+ years in medical device/IVD quality, strong regulatory and technical judgment.
3mo
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Medical Physicist, R&D
Marlborough, Massachusetts, United States
$98k-$153k/yr OnsiteFull Time
3+ YOEMaster's in Medical Physics or related field; 3+ years with Master’s or PhD; familiarity with IEC/FDA standards; medical device development experience preferred.
Medical Imaging, Imaging Systems, Quality Control, IEC 60601, IEC 62366, FDA regulations
4d
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Site Quality Assurance Engineer
Pawtucket, Rhode Island, United States
$75k-$95k/yr OnsiteFull Time
3+ YOEBS in science or engineering, 3+ years regulated environment experience (preferably medical device), strong problem-solving, familiarity with ISO 13485/14971 and FDA QSR, statistical analysis, and CAPA experience.
ISO 13485, ISO 14971, FDA QSR, GMP
2mo
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Staff Quality Engineer
Braintree, Massachusetts, United States
$109k-$150k/yr OnsiteFull Time
8+ YOEBachelor’s degree in engineering or related field with 8+ years in quality engineering in regulated medical device/life sciences environments; experience with ISO 13485, ISO 14971, FDA QSR; strong background in FMEA, CAPA, and quality system procedures.
DFMEA, PFMEA, DoE, SPC, Quality Management System, ISO 13485, ISO 14971, FDA QSR
2mo
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FSQA Quality Assurance Technician - 1st shift
Meriden, Connecticut, United States
$18/yr OnsiteFull Time
2+ YOEQA role in manufacturing; high school required; 2-3 years experience preferred; FDA/GMP knowledge preferred; basic Excel skills.
Excel
2mo
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MDI Mechanic - 3rd Shift
Fall River, Massachusetts, United States
$20-$24/hr OnsiteFull Time
2+ YOEPackaging mechanic with 2-4 years of packaging experience; high school diploma or GED; knowledge of cGMP and FDA regulations; able to communicate in English.
Machinery maintenance, Process equipment
3mo
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Molecular Imaging Account Manager, Oncology - Arizona - Blue Earth Diagnostics
Needham, Massachusetts, United States
$135k-$165k/yr OnsiteFull Time
5+ YOESell FDA-approved molecular imaging products; manage oncology territory; travel; develop key accounts; bachelor’s degree; 5+ years pharma sales.
Salesforce, CRM
4d
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Phlebotomist
Woonsocket, Rhode Island, United States
$19-$20/hr OnsiteFull Time
0.5+ YOEPerform venipuncture and plasmapheresis, monitor donors and equipment, document donor data, and follow SOPs and FDA guidelines; high school diploma and phlebotomy experience required.
Personal Digital Assistant (PDA)
2mo
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Compounding Inspector
New London, Connecticut, United States
$18-$20/hr OnsiteFull Time
High school diploma; ability to work 3rd shift; knowledge of cGMP/FDA/GLP; basic lab skills; English proficiency; strong record-keeping.
6d
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The Associate Director, MFG Training, Compliance and OpEx
Northbridge or Watertown
$150k-$190k/yr HybridFull Time
Lead design and improvement of manufacturing training, regulatory compliance (FDA, EMA, ISO), and Operational Excellence using Lean and Six Sigma across multi-site manufacturing.
2w
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Head of Quality Compliance
Framingham, Massachusetts, United States
$161k-$233k/yr OnsiteFull Time
8+ YOE8+ MgmtDegree in science and 8+ years cGMP experience, demonstrated regulatory inspection leadership, strong knowledge of FDA/EMA/ICH regulations, project management, and people leadership.
3d
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Sr Mechanical Engineer
Minneapolis or Providence
HybridFull Time
3+ YOEBachelor's in Mechanical Engineering, 3+ years medical device development experience, CAD and prototyping proficiency, familiarity with FDA/QSR/ISO, strong communication and analytical skills.
3D CAD, 2D CAD
2mo
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Statistical Programming Associate Director
Marlborough, Massachusetts, United States
$168k-$210k/yr RemoteFull Time
8+ YOE2+ Mgmt8+ years pharma programming with 2+ years of people management; strong SAS, CDISC (SDTM/ADaM), FDA submission experience; leadership and cross-functional collaboration.
SAS, CDISC, SDTM, ADaM, SAS Macros, SAS/Graph, SAS/Stat, R, Shiny
3d
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Plant Manager
Putnam, Connecticut, United States
OnsiteFull Time
10+ YOEBachelor's degree or equivalent experience,10+ years manufacturing leadership,budget and capital project experience,lean/continuous improvement and safety leadership,experience with FDA/GMP preferred.
1w
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Prin Regulatory Affairs Spec
North Haven or Mansfield or Mounds View or Boston or Lafayette
$120k-$180k/yr OnsiteFull Time
7+ YOEBachelor's degree and 7+ years regulatory experience (or advanced degree with 5+ years). Experience with 510(k), FDA interactions, international registrations, labeling and promotional material review.
2mo
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Procurement Specialist, Life Sciences Manufacturing
Coventry, Rhode Island, United States
$65k-$95k/yr OnsiteFull Time
5+ YOE5-8 years in purchasing/procurement or 8-10+ with Associate; 10+ with HS; Excel proficiency; ERP a plus; GMP/FDA experience a plus; strong organization and communication.
Microsoft Excel, ERP
2w
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Supervisor, Sample and Reagent Management
Providence, Rhode Island, United States
$59k-$69k/yr OnsiteFull Time
4+ YOEMinimum 4 years laboratory experience, high school diploma/GED, knowledge of AABB/FDA/OSHA and cGMP, experience with LIS and inventory systems, supervisory and training abilities.
Microsoft Suites, LIS, BECS
2w
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Director of Content, Cramer Health
Norwood, Massachusetts, United States
HybridFull Time
10+ YOE10+ years pharmaceutical or healthcare communications experience, strong healthcare portfolio, MLR/FDA promotional fluency, strategic presence, client-facing leadership, and agency delivery experience.
5d
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Director, Manufacturing and Quality
Franklin or Buffalo
$160k-$180k/yr OnsiteFull Time
10+ YOE10+ years manufacturing leadership in IVD/diagnostics/biopharma, bachelor's degree required (master's preferred), experience with FDA/ISO13485/GMP, Lean implementation, strong communication and leadership.
2w
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Clinical Trial Associate
Needham, Massachusetts, United States
$88k-$100k/yr HybridFull Time
2+ YOEBachelor's in health-related discipline, ≥2 years clinical research/pharma/biotech experience, GCP/FDA knowledge, EMR/databases familiarity, strong communication and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint