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
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
3w
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Clinical Documentation Specialist
Arkansas or California or Kentucky or Massachusetts or Nevada or New Mexico or Oregon or Utah or Tennessee or Texas or Wyoming
RemoteFull Time
2+ YOEMust perform concurrent and retrospective inpatient record reviews, submit compliant queries, use clinical reasoning and coding knowledge; 2+ years acute care/clinical/coding/HIM/CDI experience preferred; proficiency with EMR and Microsoft apps; relevant clinical or coding credentials required/considered.
EMR, Microsoft
2mo
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Quality Assistant
Lawrence, Massachusetts, United States
$20-$25/hr OnsiteFull Time
Support quality activities including data entry for NCRs, training, audit preparation, document control, root cause analysis, and customer interactions.
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.
1mo
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Quality Technician - 2nd Shift
Amesbury, Massachusetts, United States
$26-$31/hr OnsiteFull Time
1+ YOEHigh school diploma/GED and 1+ years quality experience. Must interpret engineered drawings, use measuring devices (calipers, micrometers, height gages), perform inspections and FAI per AS9102, complete quality documentation, and be able to obtain a DOD security clearance.
caliper, micrometer, height gage, radius gage, optical measurement system, Microsoft Word, Microsoft Excel
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
1w
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Quality Technician - Nights
Westfield, Massachusetts, United States
$20-$27/hr OnsiteFull Time
1+ YOE1-3 years related experience, high school diploma/GED, strong math, communication, attention to detail, ability to document, sample, and quarantine non-conforming material.
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
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
2w
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Quality Specialist
Methuen, Massachusetts, United States
OnsiteFull Time
0+ YOEHigh school diploma, 0-2 years QA experience (medical device preferred), GMP and ISO familiarity, calibration and documentation experience, proficiency with Microsoft Office, strong communication and problem-solving skills.
Microsoft Office
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
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
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