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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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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
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
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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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
1w
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Quality Engineer
Bourne, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor's in engineering, 3+ years quality engineering in manufacturing, experience with ISO 9001, root cause analysis, CAPA, GD&T, and strong analytical and communication skills.
1mo
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Supplier Quality Engineer III - External Operations ENDO
Marlborough, Massachusetts, United States
$82k-$156k/yr HybridFull Time
3+ YOEBS in engineering with 3+ years relevant experience; supplier quality, audits, CAPA/SCAR, process validation, design controls, project management, and ability to travel up to 25%.
PLM, ERP
2mo
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Quality Engineer
Palmer, Massachusetts, United States
$85k-$100k/yr OnsiteFull Time
3+ YOEBachelor's in Mechanical/Manufacturing/Industrial Engineering; 3-5 years quality engineering experience; ISO 9001; CAPA; PPAP; root cause analysis; data-driven; Lean.
APQP, PPAP, PFMEA, Control Plans, MSA, CMM
2w
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Associate Director, Quality Assurance GCP
United States or Waltham or Boulder
$180k-$205k/yr RemoteFull Time
8+ YOEProvide GCP QA leadership, lead audits and inspection readiness, manage CAPAs and vendor oversight; requires 8+ years GCP QA experience and a scientific bachelor's degree.
1w
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Sr. Engineer, Commissioning, Qualification, and Validation
Norwood, Massachusetts, United States
$131k-$209k/yr HybridFull Time
5+ YOEBachelor’s degree in pharmaceutical or life science and 5+ years cGMP validation/CQV experience including IQ/OQ/PQ, change controls, deviations, CAPA, and validation execution.
1mo
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Quality Assurance Specialist I
Marlborough, Massachusetts, United States
$30-$41/hr OnsiteFull Time
Experience with batch record review, GDP/ISO9001, deviations/CAPA/change control, Electronic and paper batch records, SAP and Microsoft Office. Bachelor’s preferred or equivalent experience.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, Microsoft Outlook, SAP, Electronic Batch Records, Paper Batch Records
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