1mo
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QA CAPA Engineer II
Bedford, Massachusetts, United States
$66k-$88k/yr OnsiteFull Time
2+ YOE2+ years quality or manufacturing experience in a regulated industry; BS preferred; perform RCA, implement CAPAs, statistical analysis, knowledge of ISO 13485/21 CFR 820; strong communication and Microsoft Office skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Minitab, JMP, TrackWise CAPA Management System
1mo
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Senior Quality Systems Engineer- CAPA/Complaints Support - Medical Device #8161
Boston, Massachusetts, United States
OnsiteContract, Full Time
5+ YOE5+ years medical device experience, Bachelor’s in biomedical/mechanical/electrical engineering required, experience executing CAPA, regulatory knowledge for Class II/III devices, strong analytical and problem-solving skills.
2mo
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Quality Engineer
Waltham, Massachusetts, United States
$102k-$166k/yr HybridFull Time
5+ YOEQuality engineer with data analytics experience; supplier, manufacturing, and design quality focus; CAPA and PPAP familiarity; cross-functional collaboration.
Salesforce, Arena PLM, Statistical Analysis, CAPA, PPAP
2mo
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Quality Assurance Manager
West Warwick, Rhode Island, United States
$95k-$121k/yr OnsiteFull Time
7+ YOEBachelor’s in Engineering, Quality, Manufacturing or related field; 7+ years in a regulated manufacturing environment; AS9100/ISO 9001 knowledge; audits and CAPA experience; leadership ability.
AS9100, ISO 9001, FAA, DAR, CAPA, QMS, Audit management
1w
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Quality Supervisor
Pomfret, Connecticut, United States
$75k-$90k/yr OnsiteFull Time
10+ YOE10+ years quality experience in AS9100 manufacturing, supervisory experience, inspection and measurement skills, root cause analysis, CAPA, strong communication, and Microsoft Office proficiency.
Microsoft Office, 8D, 5 Why, Fishbone Diagrams, SPC, FMEA, MSA, CAPA
1mo
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Quality Engineering Technician
East Providence or Sanford or Phoenix
OnsiteFull Time
Experience in quality or manufacturing roles, familiarity with ISO 9001/AS9100, NC/CAPA processes, document control, audit support, Excel/ERP proficiency, strong written/verbal communication and attention to detail.
Microsoft Excel, Microsoft Office, ERP, FMEA, CAPA, IPC standards
2mo
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Associate Director, Clinical Quality and Continuous Improvement
Cambridge or United States
$165k-$223k/yr RemoteFull Time
8+ YOEBachelor's in life sciences required; 8+ years in GCP Quality Assurance/Clinical Quality; experience with process improvement (DMAIC/Lean), RCA, CAPA, inspection readiness, quality metrics, and cross-functional influence.
DMAIC, Lean, Change Management, CAPA, ICH GCP
1mo
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Manager, Clinical Post Market Surveillance
Burlington, Massachusetts, United States
$99k-$199k/yr OnsiteFull Time
3+ MgmtBachelor's in biomedical engineering, nursing or related (or equivalent experience). 3+ years managing a team. Knowledge of domestic/international medical device regulations, risk assessment, CAPA and audit management, and advanced analytical and PC skills.
Quality Management System, CAPA System, External Requirements Management System, spreadsheets, word processing, database management, project management applications
1mo
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Engineer Process Development Environmental & Contamination Control
West Greenwich, Rhode Island, United States
$88k-$119k/yr OnsiteFull Time
2+ YOEEducation plus engineering/operations experience (options: HS+8yrs, Associate+6yrs, Bachelor+2yrs, or Master). Prefer 2+ years pharma/biopharma cGMP experience, strong communication, and experience with EBR/DeltaV/CAPA.
EBR, DeltaV, CAPA
5d
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Green Hydrogen Quality Engineer
Burlington, Massachusetts, United States
$110k-$160k/yr OnsiteFull Time
3+ YOEBachelor's in materials or mechanical engineering,3–7 years quality engineering in manufacturing, practical command of FMEA, SPC, MSA/Gage R&R, 8D/CAPA, ISO 9001 QMS experience, strong communication skills.
FMEA, SPC, DOE, MSA/Gage R&R, 8D, CAPA, APQP, PPAP, Design of Experiments (DOE), Six Sigma, ISO 9001, ISO 22734, IEC 62282, NFPA 2
1mo
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Quality Engineer
Randolph, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality or manufacturing engineering experience, strong QMS knowledge, root cause analysis (8D, 5 Why, Fishbone, FMEA), CAPA, SPC/MSA, ability to read drawings, and strong communication.
QMS, 8D, 5 Why, Fishbone, FMEA, CAPA, SPC, MSA, ISO 9001
4d
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Quality Engineer 3
Marlborough, Massachusetts, United States
$85k-$133k/yr OnsiteFull Time
7+ YOEBachelor's degree or equivalent,7+ years medical device quality experience,knowledge of ISO 13485,ISO 14971,FDA and EU MDR/IVDR,cAPA,CAPA,PFMEA,validation and risk management;ASQ CQE or Six Sigma preferred.
ISO 13485, ISO 14971, EU MDR, IVDR, cGMP, Six Sigma, SPC, DOE
2mo
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Final Release Specialist II - 2nd Shift
Devens, Massachusetts, United States
$23-$31/hr OnsiteFull Time
3+ YOE3+ years in medical device manufacturing with Final Release/Document Control; read blueprints; review DHRs/Batch Records; manage nonconformances and CAPAs.
ERP, QMS
3w
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Associate Director, Quality Systems - Cell and Gene Therapies (VCGT)
Boston, Massachusetts, United States
$148k-$222k/yr HybridFull Time
10+ YOEBachelor's degree and 10+ years experience in quality systems/GxP with expertise in risk management, data integrity, audits, CAPA, investigations, and project leadership.
2mo
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Quality Assurance Manager
Randolph or United States
OnsiteFull Time
3+ YOE1+ MgmtLead quality function; oversee QA/QC, FAT, CAPA, audits; bachelor's in engineering; 3+ years in quality leadership; ERP/MES experience.
ERP, MES, Epicor, SAP, Oracle, Microsoft Office
1w
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Quality Manager – Fossil Americas
Atlanta or Toronto or Detroit or Boston or Bangor or New York City or Schenectady
$94k-$156k/yr RemoteFull Time
Bachelor's in engineering or related, proven quality experience in manufacturing/field service, expertise in nonconformance, RCA/CAPA and continuous improvement, willingness to travel ~10–30%.
PowerNow Platform
2mo
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Manager, Product Complaint
Lexington, Massachusetts, United States
$97k-$107k/yr OnsiteFull Time
5+ YOEBachelor in science; 5+ years GMP biopharma experience; knowledge of GMP, 21 CFR 210/211, ICH; complaint handling, CAPA, regulatory reporting.
Veeva, Electronic Quality Events, Excel, Word, PowerPoint
2mo
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Associate Director, Quality Assurance (Cambridge, MA, US, 02142)
Cambridge, Massachusetts, United States
$165k-$223k/yr RemoteFull Time
8+ YOE8+ years in GCP/QC/QA in pharma/biotech/CRO; experience with DMAIC/Lean; strong knowledge of GCP, audits, CAPA; leadership across studies.
3w
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Senior Quality Systems Engineer
Medway, Massachusetts, United States
$93k-$116k/yr OnsiteFull Time
5+ YOEBachelor's in engineering/science or related, 5+ years related experience, ISO 13485 knowledge, audit and CAPA experience, eQMS experience, strong investigation and communication skills.
eQMS
2mo
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Manufacturing Compliance Specialist (Billerica, US)
Billerica, Massachusetts, United States
$66k-$73k/yr OnsiteFull Time
3+ YOEKnowledge of GMP and quality systems, 3+ years supporting manufacturing or quality, CAPA/change control/deviation experience, training compliance tracking, documentation and QMS familiarity.
Track Wise, EDMS, Master Control
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