1mo
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Sr. Documentation Specialist
Gainesville or Caguas or Boston or United States or Dominican Republic or Mexico or Germany or Canada or South America
OnsiteFull Time
Bachelor's degree in Engineering, Science or related; knowledge of cGMP and FDA regulations; strong documentation and communication skills; experience in regulated industries preferred; Microsoft Office proficiency; bilingual (English/Spanish) preferred.
Microsoft Office
1mo
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Quality FAI & Technical Documentation Specialist
Bristol, Rhode Island, United States
OnsiteFull Time
2+ YOE2+ years manufacturing quality control experience (preferably AS9100 aerospace); proficiency in blueprint reading, GD&T, metrology/CMM/vision inspection, MS Office; ability to prepare FAI packages and ensure traceability; must pass background check and be authorized to work in the U.S.
AS9100, ISO, NADCAP, Geometric Dimensioning and Tolerancing (GD&T), CMMs, vision inspection systems, optical comparators, ballooning and inspection software, manual and digital handheld inspection instruments, metrology tools, gauges, Microsoft Office, Microsoft Excel, Microsoft Outlook
3mo
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Documentation Control Coordinator (Contract)
Andover, Massachusetts, United States
OnsiteFull Time
3+ YOE3-5 years in documentation control; HS diploma; familiar with eQMS; knowledge of FDA 21 CFR Part 820/Part 11, ISO 13485, EU MDR; strong attention to detail and communication; MS Office proficiency.
eQMS, Microsoft Office, PDF editing
2w
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Quality Administrator
Franklin, Massachusetts, United States
$22-$27/hr OnsiteFull Time
Associate's degree preferred, experience with document control, AS9100 familiarity, SAP and Microsoft Office proficiency, attention to detail, and basic quality administration skills.
SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook
1w
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Quality Coordinator
Franklin, Massachusetts, United States
$29-$37/hr OnsiteFull Time
2+ YOE2+ years quality/document control or related experience preferred; practical ISO 9001 understanding; strong written communication; Excel, Outlook, Teams, and SharePoint skills; high school diploma or equivalent required.
NetSuite, MaintainX, SharePoint, Microsoft Excel, Microsoft Outlook, Microsoft Teams
1mo
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Quality Training Lead
Waltham or United States or Puerto Rico or North America
$78k-$113k/yr HybridFull Time
5+ YOEBachelor's degree or equivalent; minimum 5 years experience in training, learning management, quality, compliance, documentation, or QA; LMS and iLearn experience preferred; familiarity with GxP training requirements.
Learning Management Systems (LMS), iLearn
1mo
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Quality Systems Engineer
Devens, Massachusetts, United States
$75k-$104k/yr OnsiteFull Time
3+ YOE3+ years in medical device or aerospace quality with knowledge of FDA requirements, ISO 13485/AS9100/ISO9001, QMS, CAPA, NCR, document control, procedure writing, audits, and quality metrics/KPIs.
2mo
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Quality Assurance Technician
Warren, Rhode Island, United States
OnsiteFull Time
2+ YOE2-5 years in manufacturing/quality assurance; HS diploma; familiarity with ISO9001/AS9100; proficient in inspection, testing, documentation, and ERP systems.
Microsoft Word, Microsoft Excel, Access, ERP Systems, Document Control
2mo
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Quality Control Manager
Boston, Massachusetts, United States
OnsiteFull Time
2+ YOEBachelor's in engineering or construction management; 2+ years in construction quality control management; strong QA/QC, planning, and documentation skills; PM software experience.
Project management software, Construction QA/QC tools
1mo
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Quality Assurance Engineer
Foxborough, Massachusetts, United States
OnsiteFull Time
3+ YOEBachelor's in engineering or life sciences, 3+ years in FDA/ISO 13485 medical device quality environments, QMS knowledge (document control, CAPA, audits), eQMS and Microsoft Office proficiency.
Microsoft Office, eQMS, quality documentation systems
1w
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Quality Systems Manager
United States or Center Valley or Westborough or Brooklyn Park
$106k-$149k/yr RemoteFull Time
7+ YOEBachelor's degree and 7+ years in quality systems/document control/training in regulated environments; knowledge of FDA QSR and ISO 13485; DMS/LMS/EMQMS experience and strong project and communication skills.
Document Management Systems (DMS), Electronic Quality Management Systems, Learning Management Systems (LMS), Microsoft Office, ERP systems
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
2w
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Quality Technician
Southborough, Massachusetts, United States
$30-$32/hr OnsiteFull Time
Experience with calibration, first/second party audits, device history records, inspections, document control, and ISO 13485 internal auditing training preferred.
MS Office, Quality Management System (QMS)
1mo
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Senior Quality Systems Specialist
Boston, Massachusetts, United States
$95k-$105k/yr OnsiteFull Time
5+ YOE5+ years in quality assurance/systems in regulated manufacturing; experience with CAPA, deviations, investigations, change and document control, audits, SOPs, root cause analysis, QMS/ERP, and strong written documentation and cross-functional collaboration.
QMS, ERP
2w
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Quality Administrator
Franklin, Massachusetts, United States
$22-$27/hr OnsiteFull Time
Support QMS and document control per AS9100, assist audits, track nonconformances and deviation waivers, perform data entry and reporting; associate's degree preferred and SAP/MS Office experience helpful.
SAP, Microsoft Excel, Microsoft Word, Microsoft Outlook
1mo
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Supplier Quality Engineer
Suwanee or Boston or United States or Canada
$90k-$95k/yr OnsiteFull Time
8+ YOEBachelor's in engineering (or 8 yrs relevant experience), minimum 8 yrs manufacturing experience, supplier and product quality oversight (PPAP/APQP), ISO9001/ISO14001 experience, root cause analysis, documentation, travel availability, valid driver's license.
PPAP, Advanced Product Quality Planning (APQP), ISO9001, ISO14001, GD&T, Six Sigma, Lean Manufacturing
2w
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Quality Inspector - 2nd Shift
Columbia, Connecticut, United States
OnsiteFull Time
2+ YOEHigh school diploma, 2+ years inspection in manufacturing (aerospace a plus). Proficient with hand measuring instruments and GD&T, able to perform First Article/FAIR (AS9102), ISO/AS quality systems, document inspections, and comply with ITAR and US work-authorization requirements.
micrometers, calipers, height gages, optical comparator
1w
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Quality Management System Lead
Boston, Massachusetts, United States
$151k-$227k/yr OnsiteFull Time
8+ YOEManage and continuously improve QMS for GxP compliance, document control, training, records, CAPA, metrics, and audit readiness; 8+ years QA/Compliance and bachelor\u0002s in life sciences/quality required.
1w
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Quality Assurance Associate - Residential (6345)
Needham, Massachusetts, United States
$31/hr FieldFull Time
3+ YOE3+ years human services experience preferred; experience with DDS regulations, audits, data analysis, documentation review, training, and quality improvement.
HCSIS, Electronic health records
1w
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Product Quality Assurance Engineer
Chelmsford, Massachusetts, United States
$82k-$90k/yr HybridFull Time
2+ YOEBachelor's in engineering or related,2+ years quality/product engineering experience in regulated industry,experience with complaint investigations,risk management,CAPA,and documentation;strong communication and data analysis skills.