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ISO 13485 Remote Jobs

20 fresh jobs found

Senior Software Safety Engineer
USA-MN Mounds View Central, United States

Design for Reliability Software Safety Engineering Implantable Medical Devices Engineering principles DOE ISO 14971 Statistical Process Control Reliability Engineering ISO 13485 +17

Senior Full Time

USD 152K+

Quality Assurance Auditor
REMOTE- Wisconsin, United States

Medline Industries, LP

MDD Sterilization processes Method validation MDSAP ISO Standards Process Validation MDR CAPA Quality Management Systems +16

USD 72K+

Senior Quality Engineer - Trending and Data Analytics
USA-MN Mounds View South, United States

Cardiac Ablation Solutions Complaint Management ISO 14971 Quality Systems Healthcare Solutions CAPA Business Objects ISO 13485 Healthcare Access +19

Senior Full Time

USD 141K+

Quality Auditor - Level 2
Minnesota - Home based, United States

Structured Writing ISO 19011 21 CFR 820 Internal Audits ISO 13485 Medical equipment Content Management Quality Management MS Office +4

USD 60K+

Principal Quality Assurance Specialist
US-Nationwide-FIELD, United States

Cardinal Health Remote-first

E-learning Authoring Software FDA CFR 210 FDA CFR 820 Quality Management Systems ISO 13485 GMP Pay equity Learning Management Systems Validation +13

Senior Mid Full Time

USD 79K+

Compliance Operation Lead
US-DC-Remote Location, United States

Agilent Technologies

Biopharmaceutical guidelines IVDR 21 CFR 210 21 CFR 211 Corrective and preventive action CAPA management Quality operations MDSAP 21 CFR Part 11 +24

Senior Full Time

USD 111K+

Quality Audit Program Manager, Quality & Regulatory Compliance - remote
USA NJ - Franklin Lakes, United States

Quality Auditing Root-cause investigation Test Method Validation Process MDSAP Sterilization FDA QSR Environmental Monitoring EU MDR +28

Senior Full Time

USD 158K+

Senior Project Engineering Administrator, R&D (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

IEC 60601 IEC 62304 ISO 14971 Design Controls Verification and validation FDA regulations ISO 13485 Product lifecycle management Quality Management System +10

Senior Full Time

USD 92K+

Design & Development Program Manager (Remote)
Lake Forest, CA

Biomedical sciences Histopathology Budget control Assay Development ISO 13485 Genomics Process Optimization Clinical Research Risk Assessment +3

Senior Mid Full Time

USD 115K+

Manager, Global Vigilance Writing (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Medical device reporting Microsoft Office Excel Scientific Writing Medical device industry Diabetes Management ISO 13485 Diabetes Quality Management System ISO +19

USD 101K+

Expert Coach II (Mental Health)
USA - IN - Remote, United States

Asynchronous support Dialectical behavior therapy Mental Health Coaching Cognitive Behavioral Therapy Health Systems Health coaching ISO 13485 Evidence-based practices Data privacy laws +38

USD 60K+

Senior Systems Engineer (Remote/Flexible)
US - Massachusetts, United States

Insulet Corporation

Design trade-off analysis 21 CFR Part 820.30 IEC 62304 Verification planning Hazards assessment Medical Device Regulations ISO 14971 Requirements Management ISO 13485 +8

Senior Full Time

USD 101K+

Sales Director, Health Tech - CA - Remote
Los Angeles, CA, US

Vensure Employer Solutions

Patient Monitoring Devices Surgical Instruments In vitro diagnostics Health Tech ISO 13485 FDA regulations Diagnostic Imaging Cross-functional Teamwork Technical knowledge +9

Exec Senior Full Time

USD 147K+

Expert Coach II (NBC-HWC)
USA - IN - Remote, United States

ISO 13485 Health Systems Member engagement Data privacy laws Motivational interviewing Health benefits Health education Data interpretation Virtual care +35

USD 60K+

Quality Audit Program Manager, Quality & Regulatory Compliance - Remote
USA NJ - Franklin Lakes, United States

EU IVDR Validation Process Test Method MDSAP Quality Auditing Sterilization FDA QSR Root-cause investigation Environmental Monitoring +26

Senior Full Time

USD 126K+

Expert Coach II
USA - WV - Remote, United States

ISO 13485 Data privacy laws Diabetes education Motivational interviewing Health benefits Data interpretation Healthcare experience Microsoft Teams Virtual care +33

Senior Mid Full Time

USD 72K+

Director, Supplier Quality
US-PA-Remote Location, United States

Agilent Technologies

Supplier Audits Dashboard Reporting Supplier development Supplier Quality ISO 13485 Metrics Development Manufacturing processes Organizational design Pharma +23

Exec Senior Full Time

USD 150K+

Senior Manager, Health Hazard Assessment - Remote
Center Valley, PA, US, 18034-0610

Olympus Corporation of the Americas

Health hazard evaluation FDA QSR Field corrective actions 21 CFR 820 ISO 14971 ISO 13485 Cross-functional Team Leadership Regulatory requirements Operational Excellence +7

Senior Full Time

USD 114K+

Associate Principal Scientist, Device Product and Process Development
USA - New Jersey - Rahway, United States

Measurement systems analysis In silico modeling Design failure modes and effects analysis Device characterization ISO 11608 Measurement techniques FDA guidance 21 CFR 820 Analytical Instruments +58

USD 135K+

FCA Program Manager - Remote
USA-MN Mounds View South

Medical device directive FCA strategy ISO 13485 Healthcare Access FDA regulations Audit Support Medical device Reimbursement Regulatory Compliance +10

USD 166K+

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