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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
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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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.
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