182 capa jobs at 108 companies in Attleboro, MA
2mo
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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
2mo
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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
2w
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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
3w
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Design and Sustaining Quality Engineer
Clinton, Massachusetts, United States
$110k-$198k/yr OnsiteFull Time
8+ YOEBachelor's degree in engineering or equivalent experience, 8+ years in medical device quality or manufacturing engineering, Microsoft Office proficiency, data analysis, CAPA, and cross-functional leadership.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint, Power BI, Tableau, Looker, Pivot tables, Pivot charts, Six Sigma, DMADV, DMAIC, CAPA, ISO 13485
1w
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Quality Engineer – Product Quality & EHS
Westborough, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality engineering in manufacturing, knowledge of ISO/IATF standards, SPC/MSA/FMEA/APQP/PPAP/8D/CAPA, strong analytical and project skills.
SPC, MSA, FMEA, APQP, PPAP, 8D, CAPA, Microsoft Office, quality management systems
5d
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Packaging Documentation Specialist - MDI
Fall River, Massachusetts, United States
$66k-$86k/yr OnsiteFull Time
1+ YOERequires an associate or bachelor's degree and 1+ year documentation experience with 3+ years in pharmaceutical or biotech manufacturing; GMP, SOP, batch records, audits, CAPA, and problem-solving knowledge required.
Microsoft Office Suite, Microsoft Word, Microsoft Excel, SAP, MasterControl, TrackWise, FMECA, CAPA, OOS, OOT, OOAC, eBMR, BMR
6d
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, continuous improvement, data analysis, communication, and cross-functional collaboration skills required.
CAPA
6d
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Quality Systems Engineer III
Indianapolis or Plainfield or Quincy
$82k-$156k/yr RemoteFull Time
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, data analysis, problem-solving, communication, and cross-functional collaboration skills required.
CAPA
3w
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Customer Quality Engineer II
Beverly, Massachusetts, United States
$79k-$118k/yr OnsiteFull Time
3+ YOEBachelor's in engineering or related field, 3+ years quality experience in semiconductor or high-tech manufacturing, knowledge of 8D/RCA/FMEA/SPC/CAPA and ISO 9001, strong communication and analytical skills.
8D, RCA, FMEA, SPC, CAPA, Lean, Six Sigma, APQP, QMS, ISO 9001
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
5d
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Associate Director, Clinical Study Quality Lead (Hybrid)
Boston, Massachusetts, United States
$161k-$241k/yr HybridFull Time
8+ YOEBachelor's degree in a scientific or allied health field and 8+ years of relevant experience; expertise in ICH-GCP, global regulations, clinical trials, quality risk management, CAPA, metrics, and Microsoft Office.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Smartsheet, Visio, CAPA, ICH-GCP, FDA, EMA, MHRA
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
5d
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Senior Quality Manager-Advanced Imaging
Bedford, Massachusetts, United States
$134k-$213k/yr HybridFull Time
8+ YOERequires 8+ years in FDA-regulated medical device environments, quality management and design assurance leadership, medical device regulatory knowledge, CAPA and audit experience, and a bachelor's degree in quality, engineering, or a related discipline.
FDA QMSR, ISO 13485, European Medical Device Regulation (MDR), ISO 14971, 21CFR, MDD, GMP, GDP, DFMEA, PFMEA, CAPA, Lean, Six Sigma, HSA
6d
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Manager, Pharmacovigilance Case Processing
Boston or France
$131k-$150k/yr HybridFull Time
4+ YOEBachelor's degree in life science or PharmD, 4+ years of pharmacovigilance case management, global safety database experience, PV regulations knowledge, quality control, CAPA, KPI monitoring, vendor oversight, and audit expertise.
ARGUS, electronic case report forms (eCRFs), Safety Management Plans (SMP), Safety Data Exchange Agreements (SDEA), CAPA, KPI
2mo
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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
2w
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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
1w
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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
3mo
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Sr. Quality Engineer
Lowell, Massachusetts, United States
$100k-$130k/yr OnsiteFull Time
5+ YOEBachelor’s degree in STEM with 5 years of quality engineering experience; knowledge of QA systems, statistics, CAPA, and GMP.
Minitab, Microsoft Excel, Microsoft Office