137 13485 jobs at 71 companies in Massachusetts
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Senior International Regulatory Affairs Specialist
Burlington or New York City
$90k-$100k/yr HybridFull Time
5+ YOE5+ years regulatory affairs in medical devices; SiMD/SaMD; global submissions; EU MDR 2017/745; ISO 13485/14971; strong English.
Document management systems, Regulatory submission platforms, Quality Management System (QMS)
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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
2mo
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Injection Molding Process Technician B
Danvers, Massachusetts, United States
$35-$42/hr OnsiteFull Time
3+ YOEExperience in LSR molding; set up and operate LSR injection molding machines; ISO 13485/FDA familiarity; 3-5 years molding experience; English required.
LSR molding equipment, injection molding machines, auxiliary equipment, process control
3d
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Senior Quality Assurance Engineer
North Billerica, Massachusetts, United States
$120k-$140k/yr OnsiteFull Time
4+ YOEBachelor of Science in engineering or science, 4+ years in OEM medical device manufacturing, and knowledge of GMP, FDA regulations, ISO 13485, quality systems, CAPA, and electronic documentation.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, electronic document management systems, 21 CFR Part 820, ISO 13485, IVDR, GMP, CAPA, FMEA
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Quality Control Inspector II
Shrewsbury, Massachusetts, United States
$33-$40/hr OnsiteFull Time
2+ YOEInspect incoming materials and processes using precision measuring tools, interpret drawings/specifications, document results, support FAI/CA/deviations in an ISO-9001/13485 QMS.
Calipers, Micro-hite, Comparator, Microsoft Outlook, Microsoft Excel, Microsoft Word
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Product Quality Engineer
Devens, Massachusetts, United States
$75k-$94k/yr OnsiteFull Time
2+ YOE2+ years in manufacturing quality; Bachelor’s in Engineering; knowledge of root cause analysis and SPC; ISO 13485/9001/AS9100 preferred; additive manufacturing or regulated industries preferred.
SPC, Metrology, Root Cause Analysis, Quality Documentation (DHR/DMR), ISO Standards (13485/9001/AS9100)
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Plastics Injection Molding – Manufacturing Engineer II (US - Mansfield)
Mansfield, Massachusetts, United States
$74k-$112k/yr OnsiteFull Time
2+ YOE2+ years hands-on plastics injection molding experience in medical device/high-precision industry; Bachelors in Plastics Engineering; CAD (SolidWorks/AutoCAD); GMP/ISO 13485 knowledge.
CAD (SolidWorks/AutoCAD), Mold maintenance, Process monitoring, DOE, viscosity curves, cavity pressure monitoring
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 audit preparation; strong MS Office skills and attention to detail.
Microsoft Office
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Quality Records Specialist
Mansfield, Massachusetts, United States
$22-$25/hr OnsiteFull Time
3+ YOERequires 3–5 years in regulated manufacturing, preferably ISO 13485:2016, plus mechanical aptitude, communication, collaboration, attention to detail, organization, problem solving, and task management.
ISO 13485, FDA
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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
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Manager, Biomedical Services
Framingham, Massachusetts, United States
$85k-$95k/yr OnsiteFull Time
5+ YOEAssociate's degree in biomedical equipment technology or equivalent, CABT/A+ preferred, minimum 5 years servicing clinical equipment in hospitals, CMMS experience, supervisory and compliance knowledge (ISO:13485/QMS).
CMMS
5d
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Sr. Process Engineer - Assay Manufacturing
Billerica, Massachusetts, United States
OnsiteFull Time
8+ YOEBachelor's degree in a relevant engineering or scientific field and 8+ years in cGMP process engineering; FDA, ISO 13485, assay manufacturing, automation, troubleshooting, and statistical process expertise required or preferred.
Simoa, PhenoCycler, PhenoImager Fusion, PhenoCode Panels, Minitab, JMP, SPC, DoE, CAPA, SOPs, IQ/OQ/PQ, ISO 13485, FDA 21 CFR Part 820, cGMP
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Associate Director, Facilities
Milford, Massachusetts, United States
$114k-$171k/yr HybridFull Time
10+ YOELead facilities and equipment maintenance in a cGMP/ISO 13485 environment; manage preventive maintenance/CMMS, capital planning, vendors, EH&S programs, and a facilities team; 10+ years preferred.
Faciliworks, CAD, Visio, PLC
2w
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Design Assurance Engineer
Woburn, Massachusetts, United States
OnsiteFull Time
5+ YOE5+ years design assurance or product development in regulated industries; familiarity with ISO 13485/14971 and IEC 60601; bachelor's in engineering preferred; Microsoft Office proficiency; Boston-area based.
Microsoft Office
2w
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Quality Engineer II
Bedford, Massachusetts, United States
$77k-$100k/yr OnsiteFull Time
2+ YOE2+ years in regulated/controlled environments, bachelor’s in science or engineering (or equivalent), experience with quality systems, cGMP/ISO 13485/21CFR Part 820 familiarity, strong problem solving and communication.
Microsoft Excel, Microsoft PowerPoint, Microsoft Office
2d
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Vice President, Manufacturing
Andover or Somerville
$209k-$327k/yr OnsiteFull Time
15+ YOEBachelor's degree required; 15+ years of progressive manufacturing and operations leadership, regulated manufacturing experience, facility launches, automation, MES, Lean, FDA, ISO 13485, and organizational leadership experience.
MES, Lean, Six Sigma, FDA, ISO 13485
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Design Quality Assurance Engineer II
Mansfield, Massachusetts, United States
$87k-$131k/yr OnsiteFull Time
2+ YOEBachelor’s degree in engineering; 2–5 years medical device quality/design assurance; knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, MDSAP, ISO 14971.
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Cybersecurity and Data Protection Software Quality Engineer
Boston, Massachusetts, United States
$94k-$117k/yr HybridFull Time
2+ YOEBachelor's in information systems/IT, 2+ years software quality assurance or cybersecurity experience in regulated healthcare, deep IT knowledge, regulatory submission experience, familiarity with ISO 13485, IEC 62304, and ISO 14971.
Software Bill of Materials (SBOM), SPDX, CycloneDX
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Senior Regulatory Specialist
Marlborough, Massachusetts, United States
$89k-$111k/yr HybridFull Time
4+ YOEBachelor's degree in a relevant field, 4+ years regulatory medical device experience, authorized to work in the US, knowledge of ISO 13485/9001, experience with 510(k) submissions, and proficiency with Microsoft Office.
Microsoft Office, Microsoft Excel, Microsoft Word, Microsoft PowerPoint
4d
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Senior Design Quality Engineer - Electrophysiology
Waltham or Montreal or Arden Hills or Cambridge or Boston
$89k-$170k/yr HybridFull Time
6+ YOEBachelor's degree in a technical engineering discipline and 6+ years in medical device quality or design assurance; expertise in design controls, risk management, ISO 14971, 21 CFR 820, and ISO 13485.
ISO 14971, 21 CFR 820, ISO 13485, IEC 62304
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