198 quality documentation jobs at 131 companies in Lawrence, MA
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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
Mentor Technical Group: Provides engineering and compliance services for life sciences industry.
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.
TransMedicsNASDAQ: TMDX: Preserving and transporting donor organs for medical transplantation.
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.
Frontgrade Technologies: Provides mission-critical electronics for space and defense applications.
2+ YOEMinimum two years field experience in quality or manufacturing; lead quality staff, create quality documentation, conduct audits, and drive supplier and process improvements.
Valence Surface Technologies: Provides surface finishing and chemical processing for aerospace components.
Support quality activities including data entry for NCRs, training, audit preparation, document control, root cause analysis, and customer interactions.
Plansee Group: Global manufacturer of high-performance molybdenum and tungsten components.
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
MerckXETRA: MRK: A science and technology providing healthcare, life science, and electronics solutions.
1+ YOEBachelor's in engineering or science, 1+ years quality engineering experience in regulated manufacturing; knowledge of cGMP/ISO/QMS, investigations, FMEA, CAPA, data analysis (Minitab), and documentation control.
CAS Holdings: Provides industrial automation products and integrated engineering services.
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
Waltham or United States or Puerto Rico or North America
$78k-$113k/yrHybridFull Time
SanofiEuronext Paris: SAN: Researches, develops, and manufactures medicines and vaccines globally.
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.
VulcanForms: Provides industrial-scale metal additive manufacturing and precision machining services.
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.
HexcelNYSE: HXL: Produces advanced composite materials for aerospace and industrial applications.
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
The Middlesex Corporation: Constructs heavy civil infrastructure including highways, bridges, and rail.
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
PAVmed Inc.NASDAQ: PAVM: Diversified medical technology developing diagnostic and health solutions.
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
United States or Center Valley or Westborough or Brooklyn Park
$106k-$149k/yrRemoteFull Time
OlympusTokyo Stock Exchange: 7733: Manufactures medical endoscopes and minimally invasive surgical tools.
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
Optos: Develops and manufactures ultra-widefield retinal imaging devices.
Experience with calibration, first/second party audits, device history records, inspections, document control, and ISO 13485 internal auditing training preferred.
ABCorp: Produces secure payment cards and provides additive manufacturing solutions.
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.
Plansee Group: Manufactures high-performance materials and tools from molybdenum and tungsten.
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
Globus MedicalNYSE: GMED: Manufactures medical devices and robotic systems for musculoskeletal surgery.
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.
1+ YOEHigh school diploma, 1+ years quality inspection experience, ability to obtain Secret clearance, proficiency with microscopes and electronic data documentation, familiarity with IPC-A-610/J-STD-001 preferred.