159 Quality Assurance And Engineering jobs in San Jose.

Palo Alto

• Skills: Pharmacovigilance, Drug Safety, Individual Case Safety Reports (ICSRs), FDA safety regulations, ICH Guidelines, Adverse events, Study Management Teams (SMTs), Safety Management Plan (SMPs), Training documents (SOPs), Market Research and Patient Support programs (MAPs)
• Experience: Minimum of 8 years recent experience in Pharmacovigilance required; relevant pharmaceutical industry experience in drug safety required.

Hayward

• Skills: GMP, Procurement, Planning, CAR T-cell therapies, solid tumors, contract negotiation, material planning, ordering, clinical programs, cell therapy
• Type: Full-time

South San Francisco

• Skills: mechanical engineer, cell therapy, engineering subsystems, CAD design, component selection, feasibility studies, mechanical design, fluidic control, automated instrument development, cross-disciplinary collaboration

Alameda

• Skills: Quality Engineering, Medical Devices, Quality Management System (QMS), Regulatory Compliance, ISO Standards, Testing Methodology, Failure Analysis, Inspection Procedures, Statistical Techniques, Collaboration
• Experience: 2+ years of quality engineering or relevant experience, preferably in a medical devices or regulated industry environment.
• Type: Full-time
• Salary: $95,000 to $127,000

Fremont

• Skills: Quality Management System, QMS, Quality Policy, best practices, customer expectations, A.I., robotics, hardware development, key systems, creativity
• Type: Full-time

Redwood City

• Skills: QC activities, analytical data, method qualification, GMP, regulatory submissions, statistical analysis, trend analysis, SOPs, cross functional teams, cGMP/ICH/FDA regulations
• Experience: At least 5+ years (with PhD) or 8+ years (with BS) of relevant experience in AD/QC
• Type: Full-time
• Salary: $140,000 - $165,000 per year

Alameda

• Skills: Regulatory Affairs, medical devices, 510(k) submissions, CE-Mark, Quality System regulations, ISO 13485, Design Control, Regulatory Intelligence, interpersonal communication skills, organizational skills
• Experience: 2+ years of experience
• Type: Full-time
• Salary: $86,000 - $116,000 / year

South San Francisco

• Skills: Clinical Quality Assurance, GCP, pharmaceutical quality assurance, clinical trial, quality management system, regulatory requirements, stakeholder engagement, vendor management, SOP development, compliance metrics
• Experience: 8+ years of relevant experience in pharmaceutical quality assurance and compliance
• Type: Full-time
• Salary: $187,000 to $229,000

Palo Alto

• Skills: Quality Management System, compliance, regulatory requirements, continuous improvements, IVD activities, oversight, health outcomes, machine learning, blood-based tests, fragmentomics

Redwood City

• Skills: regulatory science, FDA approval, therapeutics, cellular reprogramming, manufacturing, regulatory bodies, clinical stage, project management, communication, multitasking

Alameda

• Skills: pharmacovigilance, case management, regulatory requirements, safety systems, quality management, adverse events, global reports, data analytics, compliance operations, supervisory experience
• Experience: Minimum of 17 to 21 years of experience depending on education level.
• Type: Full-time
• Salary: $351,500 - $408,000 annually

Hayward

• Skills: maintenance, mechanic, preventative maintenance, quality standards, GMP conditions, equipment, work orders, project tasks, clinical-stage, cell therapy
• Type: Contract

South San Francisco

• Skills: process engineering, cell therapy, technology transfer, manufacturing operations, automation, cGMP, process development, compliance, scalability, subject matter expert

Menlo Park

• Skills: data management, clinical trials, CDISC compliance, EDC systems, SOPs, data quality, project management, pharmacovigilance, biomedical data, data visualization
• Experience: 12+ years experience in clinical trial industry (med device, pharma or biotech), 10+ years experience in data management in clinical trial industry.

Pleasanton

• Skills: Product Management, CRM, Product Roadmap, User Stories, Agile, Collaboration, Life Sciences, SaaS, Federal Regulatory Requirements, Configuration
• Experience: 5+ years of product management experience
• Type: Full-time
• Salary: $120,000 - $200,000

Hayward

• Skills: Quality, Technician, Microbiology, Laboratory, Inspection, Quality Assurance, Quality Control, Medical Devices, Healthcare, Regulatory
• Type: Full-time

San Jose

• Skills: quality engineering, technical support, process improvement, training programs, documentation, supplier discrepancies, defect analysis, ISO documentation, quality metrics, continuous improvement
• Experience: Bachelor's degree required and two years related experience; or equivalent combination of education and experience.
• Type: Full time
• Salary: $81,900 - $147,400

Sunnyvale

• Skills: Electrical Engineering, designing, testing, analog design, medical devices, prototyping, troubleshooting, FDA compliance, cross-functional teams, documentation
• Experience: Minimum 8-12 years of relevant experience.
• Type: Full-time
• Salary: $188,600 - $271,400 USD

Santa Clara

• Skills: Manufacturing Technician, Medical Device, Preventive Maintenance, Corrective Maintenance, Equipment Installation, Process Development, GMP, Troubleshooting, Documentation, Quality Testing
• Experience: High School Diploma required with a minimum of 5 years’ experience as a manufacturing technician (or relevant experience) in the medical device industry or Associate’s degree with 3 years’ experience in the medical device industry
• Type: Full-time
• Salary: $56,200-$78,200 annually

Fremont

• Skills: clinical trials, clinical studies, Good Clinical Practice, compliance, medical devices, ISO14155, communication, project management, neuroscience, regulatory requirements
• Experience: 5+ years of academic or industry experience working with medical devices
• Type: Full-time
• Salary: $105,000 - $195,000 USD

Alameda

• Skills: Quality Engineering, Medical Devices, Testing Methodology, Inspection Documentation, Continuous Improvement, Supplier Activities, Engineering Change Orders, QC Process, Quality Management System, Regulations
• Experience: 3+ years of quality engineering or relevant experience
• Salary: $109,000/year to $152,000/year

Hayward

• Skills: Process Engineering, cell therapy, technology transfer, process comparability studies, qualification activities, manufacturing investigations, process performance, raw material qualification, process characterization, BLA readiness
• Experience: Experienced
• Type: Full-time

San Jose

• Skills: Regulatory Affairs, Consulting, Medical Device, Senior Regulatory Affairs Consultant, Senior Regulatory Affairs Associate, Labeling Operations, Regulatory Lead, Functional Service Provider, Remote, Clinical Regulatory Affairs

San Jose

• Skills: quality control, product inspection, manufacturing inspections, raw materials, complex drawings, engineering, quality engineers, packaging line, aerospace, Total Quality Management
• Experience: Minimum of 4 years of related experience as QC inspector.
• Type: Temporary
• Salary: $40,000 - $56,160

Fremont

• Skills: Manufacturing, Lyophilization, cGMP, ISO 13485, Production Planning, Technical Support, Continuous Improvement, Aseptic Techniques, Standard Operating Procedures, Troubleshooting
• Experience: 7+ years’ experience in pharmaceutical or biotechnology manufacturing or equivalent experience, with 4+ years of hands on experience in lyophilization
• Type: Full-time
• Salary: $110,000 - $130,000

Fremont

• Skills: Quality Control, proteomics, testing, ISO 13485, GMP, data analysis, assay troubleshooting, specification optimization, nonconformance resolution, process documentation
• Experience: 4+ years in Quality Control or similar environment
• Type: Full-time
• Salary: $90,000 - $105,000 + bonus + equity + benefits

Sunnyvale

• Skills: manufacturing, medical device, process validation, engineering, electro/mechanical, NPI, quality, data analysis, project management, FDA regulations
• Experience: 7 years related work experience in medical device manufacturing and product development
• Salary: $125,000 - $155,000 USD

Mountain View

• Skills: 3D modeling, CT imaging, medical imaging, visual inspection, compliance, quality assurance, healthcare, computer skills, technical program, regulated environment
• Experience: Previous experience working in a regulated industry preferred.
• Type: Full-time
• Salary: $27.72-$28.72 per hour

San Jose

• Skills: complaint handling, medical device, regulatory requirements, investigations, adverse event reporting, post market surveillance, risk file updates, ISO 13485:2016, SOPs, audits
• Experience: 5+ years of complaint-handling experience in the medical device industry
• Type: Full-time
• Salary: $120,000 - $140,000 USD

San Jose

• Skills: systems engineering, medical devices, verification, validation, requirements management, risk management, cross-functional teams, problem-solving, leadership, communication skills
• Experience: 5+ years of experience in systems engineering
• Type: Full-time
• Salary: $125,000 - $169,000 USD

Alameda

• Skills: Quality Assurance, ISO, Engineering, Manufacturing, Design Control, Statistical Analysis, Compliance, Medical Devices, Regulated Industry, Project Management
• Experience: 5+ years of relevant experience
• Salary: $125,000 to $175,000

San Jose

• Skills: quality, customer satisfaction, quality standards, corrective actions, preventive actions, quality engineering, 8D problem resolution, technical communication, semiconductor, interfacing with customers
• Experience: 10+ years
• Salary: $158,695 - $229,046

San Jose

• Skills: global trade compliance, import/export laws, trade compliance team, export control compliance, customs regulations, sanctions, ECCN, HTS codes, semiconductor trade restrictions, advanced GPU products
• Experience: 10+ years of experience in import and export global trade compliance preferred.
• Salary: $210,000 - $250,000

South San Francisco

• Skills: drug product development, formulation, manufacturing process development, cGMP, process validation, clinical trial material, regulatory submissions, DoE studies, QbD, stability study
• Experience: Minimum of 4 years with PhD, 6 years with MS, or 8 years with BS in related field
• Type: Full-time
• Salary: $160,000 - $170,000 USD annually

Santa Clara

• Skills: Quality Management System, ISO 9001, Internal audits, Document control, Corrective actions, Process improvement, Quality metrics, FMEA, External audits, Automation
• Experience: Experience building and maintaining a QMS for a semiconductor company.
• Salary: $209,000.00 – $230,000.00 USD

South San Francisco

• Skills: manufacturing engineering, quality defects, root cause analysis, countermeasures, ISO-13485, medical device, inspections, continuous improvement, collaboration, defect prevention
• Experience: 5 years in a manufacturing or quality engineering role
• Type: Full Time
• Salary: $90,000 - $210,000 a year

Sunnyvale

• Skills: Quality Assurance, Medical Device, FDA Regulations, ISO 13485, IEC 62304, Verification and Validation, Software Development Life Cycle, Risk Management, Compliance, Software Testing
• Experience: At least 3-5 years of experience in software quality engineering
• Type: Full-time
• Salary: $95,000 - $130,000 USD

Redwood City

• Skills: Regulatory Affairs, CMC strategy, licensure, submission planning, regulatory requirements, risk identification, authoring regulatory documents, collaborative work, biologics drug development, FDA submissions
• Experience: Minimum 8 years of relevant experience in CMC Regulatory Affairs
• Type: Full-time
• Salary: $185,000 to $250,000

San Mateo

• Skills: design transfer, manufacturing processes, improvement, DFM, DFA, quality, root cause analysis, pFMEA, medical device, cGMP
• Experience: 8 years experience in industry or equivalent
• Salary: $168,000-$211,000

South San Francisco

• Skills: quality assurance, Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), compliance, clinical trials, QA professionals, strategic leadership, continuous improvement, patient safety, clinical research

San Jose

• Skills: Quality Assurance, medical device, 21 CFR 820, ISO 13485, CAPA investigations, statistical tools, process improvements, GMP compliance, technical reports, ERP/MRP systems
• Experience: Minimum of 2 years of experience in Quality Assurance in the medical device field.
• Type: Full-time
• Salary: $62,400 - $80,000 a year

Palo Alto

• Skills: Patient Safety, Pharmacovigilance, Drug Safety, Compliance, Risk Management, Clinical Trials, Signal Detection, Quality Control, Regulatory Requirements, Safety Monitoring
• Experience: 5+ years’ experience in Pharma required including a thorough understanding of PV processes
• Type: Full-time
• Salary: $215-225K/year DOE

San Jose

• Skills: Software as a Medical Device, SaMD, Compliance, Quality Management System, cGMP, FDA, Risk Assessments, Customer Quality, Technical Support, Software Testing
• Experience: Minimum of 4 years of experience working in a highly regulated industry in following cGMP and GDP regulations in the areas of Research & Development (R&D), Quality (QA/QC), or Regulatory Affairs (RA).
• Type: Full Time
• Salary: 87,600.00 to 186,700.00 salary plus bonus eligible + benefits.

Sunnyvale

• Skills: mechanical design, surgical instruments, product development, mechanical parts, DFMEA, testing, automation, engineering drawings, clinical requirements, patent submissions
• Experience: Minimum BSME with at least 12 years experience, MSME with 10 years experience, or PhD with 8 years experience
• Type: Full-time
• Salary: $180,400 - $259,600 USD

Alameda

• Skills: manufacturing engineering, project management, quality system, medical device, process development, team leadership, cost effectiveness, product quality, GMP regulations, engineering support
• Experience: 5+ years of relevant experience
• Type: Full-time
• Salary: $145,000 - $214,000

San Mateo

• Skills: regulatory strategy, FDA compliance, medical devices, global regulations, submissions, clinical studies, quality management systems, risk management, inspections, team management
• Experience: 7+ years in regulatory affairs for medical devices
• Type: Hybrid

Milpitas

• Skills: Compliance, Testing, Test Plan, Test Setup, Monitoring, Quality Procedures, Design, Accreditations, Laboratory Equipment, Standards

Menlo Park

• Skills: quality engineer, molecular diagnostics, LDT, bioinformatics, process improvements, root cause analysis, CAPA, regulatory requirements, continuous improvement, statistical analysis
• Experience: Minimum of 5 years of experience within the LDT industry
• Type: Full-time
• Salary: $167,805 per year

Fremont

• Skills: Quality Management System, Continuous Improvement, Quality Engineering, Supplier Quality Management, ISO 9001:2015, AS9100:2016, Lean Manufacturing, Six Sigma, NPI, Regulatory Compliance
• Experience: Minimum of 12 years of experience in quality engineering or related area in a manufacturing environment
• Type: Full-time
• Salary: $140,000 - $180,000

Redwood City

• Skills: Quality Management, FDA regulations, ISO 13485, Process Controls, Risk Management, Validation, Continual Improvement, Internal Audits, Statistical Process Control, Change Control