133 Quality Assurance And Engineering jobs in Remote - United States.

United States

• Skills: regulatory affairs, quality systems, marketing authorization, in vitro diagnostics, CDx, regulatory submissions, global clearance, business development, clinical protocols, FDA PMA
• Experience: Minimum 5+ years of experience in a medical device, pharmaceutical management, clinical trial, and/or pharmaceutical services consulting environment, or in vitro diagnostics, preferably with CDx.
• Type: Full-time
• Salary: $110,000 — $160,000 USD

United States

• Skills: regulatory submissions, regulatory strategy, cardiac electrophysiology, regulatory bodies, project management, mentoring, clinical research, healthcare compliance, quality assurance, medical device
• Experience: Experience in regulatory affairs, specifically in cardiac electrophysiology, as well as management experience.

United States

• Skills: regulatory affairs, healthcare consulting, clinical trials, in vitro diagnostics, CDx, regulatory submissions, business development, FDA PMA, quality systems, market authorization
• Experience: Minimum 2+ years of applicable consulting experience with a focus in regulatory affairs; Minimum of 5+ years of experience working in a medical device, pharmaceutical management, clinical trial and/or pharmaceutical services consulting environment.
• Type: Full-time
• Salary: $110,000 — $160,000 USD

United States

• Skills: QA Manager, Radiation Oncology, quality assurance, product quality management, treatment planning, AI-driven contours, testing, troubleshooting, medical physicist, Regulatory Team
• Experience: Highly motivated medical physicist with a passion for radiation therapy
• Type: Full-time

United States

• Skills: Supplier Quality Engineer, Quality Management Systems (QMS), ISO9001, Supplier audits, Continuous Improvement, 8D problem-solving, GMP, Lean/Six Sigma, Process validation, CAD tools
• Experience: 5+ years of experience working as a supplier quality engineer in a similar fast-paced industry
• Type: Contract

United States

• Skills: Project Management, LIMS, Stakeholder Management, Cloud Technologies, GxP-compliant Systems, Requirements Development, Testing, Validation, Data-Driven Approaches, Change Management
• Experience: 3+ years managing projects, 2+ years configuring and managing a LIMS
• Type: Full-time

United States

• Skills: Technical Services, Healthcare, Innovation, Medical Devices, Customer Support, Clinical Education, Supply Chain, Sales, Quality, Engineering
• Type: Full time

United States

• Skills: Quality Assurance, Auditor, GCP, GXP, Clinical Research, Regulatory Compliance, Biologics, Documentation, Risk Management, Data Integrity

United States

• Skills: CMC Regulatory Affairs, project management, healthcare products, medical devices, cosmetics, regulatory strategies, product development, quality management, technical documentation, compliance
• Experience: Minimum of 7 years of relevant work experience, preferably in CMC Regulatory Affairs or R&D.

United States

• Skills: Senior Medical Device Auditor, audits, ISO 13485, MDSAP, MDD, MDR, medical devices, audit teams, certification, training
• Experience: Must have experience with ophthalmology medical devices

United States

• Skills: Consulting, Regulatory Affairs, Clinical Research, Project Management, Biologics, Medical Devices, Submissions, Regulatory Strategy, Functional Service Provider, Technical Leadership

United States

• Skills: Quality Assurance, Medical Writing, Healthcare, Clinical Research, Compliance, Regulatory Affairs, Patient Care, Innovation, Manufacturing, Diversity
• Type: Full-time

United States

• Skills: Quality Cloud, implementation, consulting services, Life Sciences, proposals, stakeholder engagement, software implementation, project charter, GxP Training, compliance
• Experience: 5+ years of experience delivering consulting services
• Type: Full-time
• Salary: $85,000 - $170,000

United States

• Skills: Regulatory Affairs, Consulting, Biologics, Clinical Research, CMC, Submissions, Project Management, Medical Device, Outcomes Assessment, Functional Service Provider
• Type: Various

United States

• Skills: Engagement Management, Quality Consulting, Life Sciences, Project Management, Business Development, Consulting Experience, Client Relationship Management, Pharmaceutical, MedTech, Leadership
• Experience: 8+ years of consulting experience in an established strategic/management consulting organization
• Type: Full-time
• Salary: $85,000 - $210,000

United States

• Skills: Healthcare, Medical Devices, Sales, Quality, Finance, Engineering, Operations, Supply Chain, Information Technology, Compliance
• Type: Full-time

United States

• Skills: Pharmacovigilance, Drug Safety, Quality Management, Regulatory Affairs, Compliance, Project Management, Procedural Documentation, Training Compliance, Audits, Metrics
• Experience: 7+ years in Pharmacovigilance/Drug Safety, Regulatory Affairs or Quality Assurance in the pharmaceutical/biotech industry
• Type: Contract
• Salary: $154,800.00 - $252,800.00

United States

• Skills: Quality management, Manufacturing, Automotive, Process optimization, Continuous improvement, Regulatory compliance, Team leadership, Data analysis, Training, Project management
• Experience: 12-15+ years of experience
• Type: Full time

United States

• Skills: IVD, Regulatory, Quality, Safety, Clinical, Operations, Drug development, CDx, Leadership, Strategy
• Experience: Doctorate degree and 4 years of directly related industry experience OR Master’s degree and 7 years of directly related industry experience OR Bachelor’s degree and 9 years of directly related industry experience
• Type: Full time
• Salary: 181,245.00 USD - 214,524.00 USD

United States

• Skills: product quality, biotechnology, regulatory, clinical development, commercialization, quality assurance, risk management, cross-functional, stakeholder engagement, cGMP
• Experience: 12+ years of experience with Biotechnology, Pharmaceutical, Medical Device or other, highly regulated, industry; preferred experience in gene therapy or biologics product development

United States

• Skills: regulatory management, project management, biotech, NDA, MAA, Veeva RIM, eCTD, filings, timeline management, critical thinking
• Experience: 3+ years in regulatory project management
• Type: Full-time
• Salary: $150,000 - $220,000 USD

United States

• Skills: medical writing, clinical development, regulatory documents, pharmacovigilance, cross-functional teams, AI tools, Good Clinical Practice, document author, stylish guidelines, continuous improvement
• Experience: 7+ years in the development of clinical and regulatory documents
• Type: Hybrid
• Salary: $250,000 - $300,000 for NYC and Boston; $238,000 - $285,000 for other eligible remote locations

United States

• Skills: clinical research, dental industry, product development, ISO 14155, MDR, medical device, team management, investigator-initiated studies, scientific communication, regulatory compliance
• Experience: Minimum of 10+ years of experience in clinical research with a focus on dentistry.

United States

• Skills: Regulatory Affairs, regulatory requirements, cross-functional collaboration, product registrations, global regulatory approvals, FDA submissions, risk management, regulatory surveillance, Quality System management, medical device
• Experience: 1-3 years
• Type: Full-time
• Salary: $90,000 - $105,000

United States

• Skills: quality management, regulatory compliance, R&D processes, continuous improvement, risk management, documentation, FDA, ISO, cross-functional collaboration, product development
• Experience: Minimum of 10+ years of experience in quality management within the R&D or product development environment, with at least 5 years in a leadership role.
• Type: Full time
• Salary: $180K – $210K

United States

• Skills: Project Engineering, Aseptic Operations, Technical Documentation, Cost Estimation, Supplier Management, Risk Assessment, Qualification Protocols, Compliance, Project Strategy, GMP
• Type: Full-time

United States

• Skills: regulatory compliance, fragrance, SDS preparation, IFRA, REACH, FDA, EPA, technical documentation, product registrations, risk assessments
• Experience: Minimum of 3-5 years of experience in regulatory affairs
• Type: Full time

United States

• Skills: clinical trial, documentation framework, regulatory compliance, SOPs, transformation strategy, process documentation, cross-functional, operational excellence, quality, change management
• Type: Full time
• Salary: 179,156.00 USD - 211,501.00 USD

United States

• Skills: Pharmacovigilance, Safety, Implementation, Life Sciences, Customer Success, Drug Safety, GxP software, Configuration, Validation, Training
• Experience: 3+ years of experience in Life Sciences, Healthcare, or an adjacent Safety industry
• Type: Full-time
• Salary: $80,000 - $200,000

United States

• Skills: computing system validation, quality assurance, biotechnology, pharmaceutical, regulatory compliance, risk management, data integrity, leadership, cross-functional collaboration, validation documentation
• Experience: Minimum of 10 years of experience in computer system validation (CSV) within a biotechnology, pharmaceutical, and/or medical device industry with at least 3 years in a leadership role focused on quality assurance.
• Type: Full-time
• Salary: $200,000 - $225,000/year

United States

• Skills: quality assurance, product quality, GMP systems, collaboration, document approval, deviation investigations, root cause analysis, CAPAs, international quality, clinical products
• Type: Full-time
• Salary: 109,307.00 USD - 129,509.00 USD

United States

• Skills: Quality Management System, Compliance, ISO13485, Continuous Improvement, Quality Assurance, Process Improvement, Team Leadership, Project Management, Regulatory Requirements, Cross-functional Collaboration
• Experience: 8+ years quality leadership experience
• Type: Full-time
• Salary: $357,408 per year, including a base pay range of $213,282 - $234,090 per year.

United States

• Skills: quality assurance, compliance, innovation, external partnerships, testing facilities, post-market, technical transfer, go-to-market, suppliers, third-party pharmacy

United States

• Skills: regulatory labeling, labeling governance, labeling process, health authority interactions, core labels, CCDS, project management, scientific information, local labeling, continuous improvement
• Experience: 5+ years of direct experience in regulatory affairs global labeling
• Type: Full-Time

United States

• Skills: auditing, compliance, clinical research, quality management, SOPs, training, CAPA, regulatory inspections, vendor audits, quality systems
• Experience: 4 years industry experience

United States

• Skills: Quality Management System, SOPs, CAPA, documentation, training, client audits, regulatory inspections, vendor audits, internal audits, compliance
• Experience: 4 years industry experience

United States

• Skills: Lead Auditor, ISO 22716, EU GMP, WHO GMP, EFfCI, EXCiPACT, ISO 15378, ISO 9001, Sustainability, SGS Certification
• Type: Full-time

United States

• Skills: Product Management, Healthcare IT, Regulatory Compliance, FHIR, Interoperability, Agile Methodologies, HL7 Standards, CMS, TJC, Regulatory Strategy
• Experience: 5+ years of experience in healthcare IT or a related field, 3+ years of product management experience
• Type: Remote
• Salary: $90,000 - $110,000 USD

United States

• Skills: Project Management, Pharmaceutical Compounding, Quality Management Systems, Regulatory Requirements, Risk Management, Team Leadership, Stakeholder Management, Process Improvement, Compliance, Cross-functional Collaboration
• Experience: 12+ years of project management experience in the Pharmaceutical industry
• Type: Full time
• Salary: $150K – $180K

United States

• Skills: Medical Devices, Technical File Reviews, CE Marking, Regulatory Compliance, Product Assessment, Medical Device Directive, Technical Documentation, Client Communication, Service Delivery, Risk Management

United States

• Skills: regulatory affairs, clinical trials, FDA, EMA, regulatory submissions, compliance, oncology, cell therapy, ICH/GCP guidelines, adverse events
• Experience: Minimum of 3 years of experience in regulatory affairs, supporting clinical trials.
• Type: Full-time

United States

• Skills: Epic Certification, Epic Systems, SQL, Report Development, Data Analysis, Healthcare Industry Experience, Regulatory Compliance, Quality Reporting, Problem-Solving, Project Management

United States

• Skills: Senior Editor, regulatory submission documents, quality control, nonclinical, editing, QC checklists, drug development, communication skills, document management platforms, bioanalytical sciences
• Experience: Minimum of 4 years of experience editing, formatting, drafting, or reviewing regulatory submission documents
• Type: Contract
• Salary: $70,700.00 - $115,100.00

United States

• Skills: Sterile NPI, project management, pharmaceutical, product development, regulatory frameworks, sterile manufacturing, formulation, process development, tech transfer, cGMP
• Experience: 7+ years of project management experience in pharmaceutical or biotech product development; experience with sterile manufacturing required.
• Type: Full time
• Salary: $115K – $150K

United States

• Skills: Regulatory labeling, labeling strategies, CCDS, USPI, EU SmPC, product lifecycle, FDA regulations, clinical trials, labeling documents, risk management
• Experience: 3 - 4+ years of related Biotech or Pharma industry experience
• Type: Contract
• Salary: $148,300.00 - $241,900.00

United States

• Skills: GMP, QA, QC, compliance, audits, continuous improvement, manufacturing, biotechnology, pharmaceutical, leadership
• Experience: 10-15+ years in GMP, quality assurance, or manufacturing within the biotechnology or pharmaceutical industry standards.
• Salary: $245,000 to $273,000

United States

• Skills: biologic/device combination products, prefilled syringes, autoinjectors, design control documentation, cGMP, regulatory submissions, quality management system, manufacturing protocols, risk management, clinical development
• Experience: Minimum 10 years of relevant industry experience
• Type: Full-time
• Salary: $180,000-$205,000

United States

• Skills: clinical data management, data review, data cleaning, query management, data reconciliation, study protocols, data quality trends, cross-functional data review, EDC design, CDISC
• Experience: Minimum of 3-5 years of data management experience in the biotech, pharmaceutical and/or CRO setting; as well as experience with global studies.
• Type: Remote
• Salary: $150,000 - $185,000 USD

United States

• Skills: Quality Assurance, Radiation Oncology, Medical Physics, Product Testing, Regulatory Compliance, Problem Solving, Clinical Skills, Workflow Automation, Product Quality Management, Documentation

United States

• Skills: Quality Assurance, GMP compliance, dietary supplements, FDA regulations, product quality, complaints processing, Supplier Qualification, Certificates of Analysis, critical thinking, collaboration
• Experience: 3+ years of direct US dietary supplement/Consumer Healthcare Quality experience
• Type: Full-time
• Salary: $70,000 - $85,000 USD

United States

• Skills: Product Management, Life Sciences, Validation, Agile, Data Modeling, JIRA, Confluence, GMP, Pharmaceutical Manufacturing, Digital Product Design
• Experience: 3+ years of Product Management or relevant work experience
• Type: Full-time
• Salary: $75,000 - $165,000