108 Quality Assurance And Engineering jobs in Boston.

Cambridge

• Skills: medical writing, regulatory submissions, clinical data, cross-functional collaboration, document management, project management, regulatory compliance, Common Technical Document, quality control, standard operating procedures
• Experience: 7+ years of experience in medical/clinical/regulatory writing in the pharmaceutical/biotechnology/healthcare industry; 3+ years of regulatory document project management oversight/experience

Lexington

• Skills: GMP, viral vectors, cGMP, SOPs, Cell Culture, Purification, Batch Production Records, troubleshooting, manufacturing operations, aseptic techniques
• Experience: 2-4 years related cGMP industry experience or an Associate’s Degree in Life Sciences/Engineering field with 1 year of cGMP Manufacturing experience or Bachelor’s degree in life Sciences/Engineering field
• Type: Full-time

Boston

• Skills: biomanufacturing, Project Management, cell and gene therapy, pharmaceutical, validation, quality compliance, technical delivery, engineering, supply chain, patient focused
• Experience: 0-3 years of consulting and/or project engineer experience
• Type: Full-time
• Salary: Competitive salary based on experience

Boston

• Skills: Quality Engineer, Vault Infrastructure, SaaS platform, life sciences, pharmaceuticals, biotechnology, medical devices, infrastructure modules, collaboration, fast-paced setting
• Experience: Graduate or about to graduate
• Type: Full-time

Cambridge

• Skills: Environmental Health & Safety, EH&S programs, biopharma, safety protocols, regulatory compliance, employee safety, hazardous materials, incident preparedness, culture of continuous improvement, industry certification
• Experience: 10+ years of EH&S experience, with focus on building strong EH&S culture and leading teams to EH&S excellence.
• Type: Full-time

Burlington

• Skills: mechanical designs, medical devices, diagnostic devices, injection molding, automated assembly, rapid prototyping, engineering tests, 3D modeling, cross-functional teams, ISO 13485
• Experience: 3+ years
• Type: Full-time

Lexington

• Skills: Quality Management System, GMP, cGMP, deviations, Corrective and Preventive Actions (CAPAs), investigations, change controls, batch record review, data integrity, biologics/gene therapy
• Experience: 3-5 years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment

Cambridge

• Skills: Sterilization, Biotechnology, Healthcare, Gas sterilization, Process validation, Regulatory compliance, Collaboration, Technical lead, Quality assurance, Project management
• Experience: 4+ years of Engineering experience
• Type: Full-time
• Salary: 119,195.00 USD - 147,867.00 USD

Chelmsford

• Skills: Quality Assurance, Quality Engineering, Manufacturing, Continuous Improvement, FDA, ISO, CAPAs, Team Management, Process Optimization, Supplier Quality
• Experience: Minimum of 5 years related quality experience in a manufacturing environment; Minimum of 2 years of supervisory or management experience.

Quincy

• Skills: Quality Assurance, manufacturing, risk assessment, wear-test program, collaboration, corrective action, regulatory compliance, quality control, product development, sourcing strategy
• Experience: 3+ years related experience.
• Type: Full-time

Cambridge

• Skills: regulatory strategies, compliance, medical devices, global regulatory oversight, product lifecycle management, cross-functional collaboration, regulatory submissions, health authority interactions, risk management, team leadership
• Experience: Minimum of 12 years of industry experience in Medical Device and Combination Products Regulatory Affairs, including 8 years leading Global Regulatory Affairs teams.
• Type: Full-time
• Salary: $184,000-$253,000

Cambridge

• Skills: design transfer, medical devices, manufacturing processes, regulatory requirements, engineering testing, vendor management, process validation, continuous improvement, CAD, quality management
• Experience: 4 years of Engineering experience with a Bachelor's degree, or 2 years with a Master's degree, or equivalent experience.
• Type: Full-time
• Salary: 119,195.00 USD - 147,867.00 USD

Chelmsford

• Skills: Quality Engineer, Design Assurance, Process Validation, Risk Management, Statistical Techniques, Process Controls, Documentation, Audits, Root Cause Analysis, Medical Device
• Experience: 2 to 5 years of quality engineering or design assurance experience (preferably in the medical device industry)
• Type: Contract

Boston

• Skills: program management, software delivery, Life Sciences, Healthcare, Quality Vault, implementation programs, customer success, project execution, strategic relationships, GxP technology
• Experience: 12+ years in large-scale program management with software delivery in the Life Sciences or Healthcare sectors
• Type: Full-time
• Salary: $100,000 - $200,000

Cambridge

• Skills: Medical Device, Design Control, Documentation, Engineering, Risk Assessment, Regulatory Compliance, Quality Management, Documentation Authoring, Drug Delivery Devices, Cross-functional Team
• Experience: 2 years of Engineering experience with a Bachelor’s degree; or 6 years with an Associate’s degree; or 8 years of Engineering experience with a high school diploma/GED.
• Type: Full time
• Salary: 93,344.00 USD - 107,268.00 USD

Boston

• Skills: program management, Quality Vault implementations, customer success, strategic oversight, governance, IT relationships, executive communication, large programs, technology strategy, GxP implementations
• Experience: 12+ years in large-scale program management with software delivery in the Life Sciences or Healthcare sectors
• Type: Full-time
• Salary: $100,000 - $200,000

Marlborough

• Skills: Quality Assurance, Design Control, Validation, Root Cause Analysis, Manufacturing processes, ISO requirements, CAPAs, Document Control, Statistical analysis, Improvement projects
• Experience: Five to Eight years related experience in IVD, medical, pharmaceutical, or other related industry.
• Type: Full-Time

Cambridge

• Skills: Computer System Validation, FDA compliance, GMP, validation documentation, risk assessments, collaboration, quality compliance, validation protocols, change controls, GxP-regulated systems
• Experience: 5+ years of relevant work experience
• Type: Contract
• Salary: $82,600.00 - $134,800.00

Framingham

• Skills: Product Quality, Safety, Regulatory Compliance, Risk Management, Quality Assurance, Consumer Expectations, Data Analysis, Documentation, Cross-functional Teams, Continuous Improvement
• Experience: 3+ years of experience in Product quality assurance, product safety, quality engineering, or a related field.
• Type: On-site

Cambridge

• Skills: regulatory submissions, submission management, cross-functional teams, NDA, MAA, submission planning, project management, quality standards, critical path activities, continuous improvement
• Type: Hybrid

Woburn

• Skills: Systems Engineering, risk management, regulatory compliance, project leadership, biotechnology, medical devices, FDA, quality control, collaboration, data analysis
• Experience: 8+ years of engineering experience, 5+ of Systems Engineering.
• Type: Full Time

Cambridge

• Skills: Regulatory Affairs, Consulting, Clinical, Remote, Associate, Senior, Device, Medical, Drug, Lead

Cambridge

• Skills: downstream development, viral vector purification, AAV manufacturing, experiments, tech-transfer, analytical data, process optimization, chromatography, filtration, documentation
• Experience: 3+ years (BS) or 0 years (MS) experience in the biotech industry, including internships or co-op experience
• Type: Full-time
• Salary: $87,000 to $130,000

Chelmsford

• Skills: Design Assurance, New Product Development, Risk Management, Test Method Development, Validation, Design Verification, Regulatory Affairs, Hazard Analysis, DFMEA, Test Protocols
• Experience: Two years of related experience required.

Boston

• Skills: BMS, EMS, Automation Systems, GxP, Maintenance, Operational Proficiency, Safety Compliance, Troubleshooting, Preventive Maintenance, Project Coordination
• Type: Full-time

Waltham

• Skills: GMP, QC testing, stability management, analytical development, quality systems, regulatory submissions, data analysis, CROs, collaboration, communication
• Experience: 4-6 years’ experience in GMP QC testing and/or QC stability management

Boston

• 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

Peabody

• Skills: Project Management, Supplier Management, Quality Inspection, Supply Chain, Healthcare Innovation, Medical Device, Engineering, Process Validation, Statistical Analysis, Regulatory Compliance
• Experience: 3+ years of professional experience
• Type: Hybrid
• Salary: $108,800 to $147,200

Waltham

• Skills: Clinical Quality Assurance, Compliance, GCP, GLP, Regulatory, Clinical Development, Quality Systems, Audit, Training, Pharma/Biotech
• Experience: A minimum of 6 years relevant GCP experience in pharma/biotech company
• Type: Full-time

Boston

• Skills: customer success, client operations, professional services, systems engineer, Solutions Architect, Software as a Medical Device, SaMD, product management, technology, quality
• Experience: Minimum of 1 year professional experience (internships included) in the SaaS industry.
• Type: Full-time
• Salary: $65,000 - $90,000

Boston

• Skills: Customer Quality, Quality Improvement, Quality Requirements, Customer Complaints, Corrective Action, Continuous Improvement, PPAP, VOC, Customer Interface, Engineering
• Experience: 5+ years of Experience in Quality
• Type: Full-time
• Salary: $98,600–$147,800

Waltham

• Skills: clinical supply, inventory management, drug development, compliance, project management, contract manufacturing, GxP, IVRS, CRO, deviations
• Experience: Minimum of 5 years of related experience in the pharmaceutical industry with at least 3 years of direct experience in Global Clinical Supply Management.

Boston

• Skills: laser systems, quantum computing, optical engineering, R&D, cross-functional collaboration, system integration, laser technologies, safety regulations, productization, high-precision
• Experience: Ph.D. in Optical Engineering, Physics, Electrical Engineering, or a related field. Exceptional candidates with a Master's degree and significant experience will also be considered.

Somerville

• Skills: clinical supply chain, biotechnology, clinical labeling, packaging, distribution, clinical trial material, vendor management, GMP, global regulatory compliance, Gene Editing
• Experience: 12+ years of clinical supply chain experience or Master's degree with 10+ years of experience.
• Type: Full-time

Boston

• Skills: Commissioning, Qualification, Validation, pharmaceutical manufacturing, protocol writing, troubleshooting, documentation, project management, regulatory compliance, team coordination
• Experience: 4-12 years
• Type: Full-time
• Salary: $102,100 - $111,700 a year

Boston

• Skills: regulatory, CMC, gene therapy, biologics, ATMP, documentation, compliance, submission, collaboration, product lifecycle
• Experience: Minimum 3 years of regulatory CMC experience with biologics and/or Advanced Therapy Medicinal Products (ATMPs).
• Type: Full-time

Waltham

• Skills: Quality Assurance, GCP, GLP, Pharmacovigilance, QA systems, risk management, regulatory compliance, audit programs, regulatory inspections, continuous improvement
• Experience: 15+ years related experience, preferably in life sciences with 8+ years in GCP/GLP Quality and PV Quality
• Type: Full-time
• Salary: $269,000-$329,000

Peabody

• Skills: Equipment Engineering, Preventative Maintenance, Calibration, Good Manufacturing Practices, Validation, Troubleshooting, Production Manufacturing, Technical Support, Continuous Improvement, Medical Devices
• Experience: Minimum of 5 years of experience in equipment engineering, preferably in the medical device manufacturing industry.
• Type: Full-time
• Salary: $105,000-$169,050

Watertown

• Skills: Supply Chain, Clinical Supply Chain, Manufacturing, Inventory Control, Production Planning, Material Enrollment, Customer Satisfaction, GMP Compliance, KPI Monitoring, Continuous Improvement
• Experience: 5+ years of experience working in a cGMP role with on-site manufacturing required.
• Type: Full-time

Boston

• Skills: validation, project management, engineering, quality/compliance, teamwork, problem-solving, GxP best practices, technical documents, manufacturing processes, cross-functional collaboration
• Experience: Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience.
• Type: Full-time
• Salary: $50,000 - $240,000 USD

Marlborough

• Skills: cosmetics, OTC liquids, regulatory compliance, product development, safety testing, formulation, manufacturing compliance, claims, labeling laws, cGMP
• Experience: 15+ years in a cosmetic regulatory role
• Type: Hybrid

Cambridge

• Skills: clinical, compliance, Quality Assurance, ICH/GCP, clinical studies, regulatory inspections, eTMF, SOPs, team rosters, training matrices
• Experience: 5+ years of pharmaceutical or biotechnology industry experience
• Type: Remote friendly

Boston

• Skills: Quality Systems, Regulatory Affairs, Medical Devices, Regulatory Submissions, Quality Management System, Post-market Processes, Compliance, Product Development, Consumer Wearable, Problem-solving

Watertown

• Skills: Quality Assurance, GMP, cell therapy, manufacturing, documentation, compliance, batch records, investigations, continuous improvement, performance objectives
• Experience: 6-8 years in a biotechnology manufacturing environment
• Type: Full-time

Boston

• Skills: Clinical Operations, IT, biopharmaceutical, computer system validation, GxP, regulatory compliance, project management, stakeholder engagement, risk-based approach, system integrations
• Experience: 10+ years’ experience in Clinical Operations, IT, or related function in a biopharmaceutical setting.
• Type: Full-time

Cambridge

• Skills: facilities management, biotech, pharmaceutical, life sciences, buildout, operations, vendor management, compliance, safety, collaboration
• Experience: 10+ years of experience in facilities management, ideally within a biotech, pharmaceutical, or life sciences environment.

Woburn

• Skills: regulatory submissions, FDA, license renewals, registration, compliance, quality system, advertising, clinical trial, regulatory assessments, post-market compliance

Boston

• 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

Cambridge

• Skills: Quality Management System, vendor management, GxP, auditing, compliance, continuous improvement, risk assessment, Quality ambassador, Veeva QualityDocs, Inspection Readiness
• Experience: 4+ years of experience in pharma/biotech Vendor Management and auditing.

Boston

• Skills: Document Control, GxP, Quality, Regulatory, Standard Operating Procedures, Training, Compliance, Records Management, Electronic Document Management Systems, Project Management
• Experience: 6-8 years
• Type: Hybrid

Waltham

• Skills: pharmacovigilance, signal detection, risk management, regulatory compliance, documentation, training and development, safety reports, data analysis, collaboration, Good Pharmacovigilance Practices
• Experience: Minimum of 10 years of experience in pharmacovigilance, with at least 2 years in a leadership role

Cambridge

• Skills: Quality Systems, Compliance, GxP Training, Inspection Readiness, Regulatory Standards, Document Control, Cross-departmental Communication, Quality Control, Pharmaceutical Industry, eDMS
• Experience: 2 years of experience in a quality function in pharmaceutical and/or medical devices.
• Type: Full-time

Cambridge

• Skills: Inventory Management, Supply Chain, Forecasting, Clinical Supply, Demand Analysis, Supply Planning, Inventory Reconciliation, QMS, Supply Chain Systems, GxP
• Experience: 5+ years of relevant experience in the Pharmaceutical Industry or relevant educational background

Cambridge

• Skills: regulatory strategies, FDA interaction, clinical development, regulatory filings, regulatory agency interface, strategic guidance, collaborations, vendor oversight, clinical trials, CMC regulatory
• Experience: Leading regulatory affairs at a growth-stage biotech, experience in relevant therapeutic areas such as psychiatry or neurology, strong track record in Regulatory Affairs and CMC Regulatory, including hands-on experience in Phase II clinical trials.
• Type: Full-time
• Salary: $335,000 to $365,000

Boston

• Skills: Medical Device Sales, medical device software, software as medical device, SaMD, Software systems engineer, software in a medical device, SiMD, software systems engineering, software verification, software validation
• Experience: Minimum of 2 years of experience in customer success, technical support, sales engineering, or related.
• Type: Full-time
• Salary: $100,000 - $110,000 base + equity options *OTE may be negotiated based on experience level

Woburn

• Skills: radiopharmaceutical, radiochemistry, product development, clinical studies, regulatory submission, manufacturing processes, product design, clinical application, commercialization, project management

Cambridge

• Skills: GxP, Quality, Regulatory Compliance, GMP, GCP, GLP, Quality Systems, Post-market Surveillance, Global Operations, Leadership
• Experience: 15+ years of experience in biopharmaceutical Quality leadership roles
• Type: Full-Time

Waltham

• Skills: analytical development, quality control, QC, analytical methods, validation, cGMP, biologics, small molecules, regulatory, CMC
• Experience: 2 years in Analytical Development or QC or R&D, including analytical tools and practices for biologics and small molecules

Marlborough

• Skills: Regulatory Affairs, medical devices, FDA regulations, EU MDR, product development, submissions, compliance, regulatory strategies, clinical trials, sustaining engineering
• Experience: Minimum 4 years in Regulatory Affairs or related discipline in medical devices or drugs
• Type: Hybrid
• Salary: $82,600 - $156,900

Cambridge

• Skills: GxP, GCP, GLP, Quality Assurance, Regulatory Compliance, Audit, CAPA, RCA, Quality Management System, Clinical Research
• Experience: At least 10 years within pharmaceutical and/or biotech industry
• Type: Full-time
• Salary: $175,000 to $215,000 depending on experience plus bonus, equity, and benefits

Waltham

• Skills: Quality Management, GxP Systems, Regulatory Compliance, Quality Assurance, SOP Development, Audit Management, Vendor Qualification, CAPAs, Validation, Quality Trends
• Experience: 15+ years in pharmaceutical quality systems and GxP Systems
• Type: Full-time
• Salary: $257,000-$314,000 annually

Boston

• Skills: Pharmacovigilance, Gene Therapy, Regulatory Compliance, Patient Safety, Global Strategy, Risk Assessment, Regulatory Submissions, Leadership, Biotech, Orphan Diseases

Quincy

• Skills: assemble, operate equipment, inspect in-process medical devices, maintain quality, building product, production goals, quality assurance, manufacturing process, compliance, regulatory policies
• Experience: 0 Years with high school diploma/degree/equivalent
• Type: Onsite
• Salary: $32,552 - $55,328

Boston

• Skills: Systems Engineering, Testing, Orthopaedics, Digital Technology, Robotics, Medical Devices, Requirements Analysis, Validation and Verification, Risk Management, Product Development

Marlborough

• Skills: Quality Systems Engineer, Supplier QA, Medical Device, Quality initiatives, Compliance, Cross functional projects, Continuous improvement, Material controls, FDA regulations, ISO 13485
• Experience: 5+ years with Bachelor's degree or 3+ years with Master's degree in a medical device manufacturing, quality or regulatory/compliance environment
• Type: Hybrid
• Salary: $103700 - $197000

Boston

• Skills: Product Management, Healthcare Quality, CMS Regulations, Software Development, Product Owner, Quality Measurement, Regulatory Affairs, Data Platforms, Client Interaction, Analytical Skills
• Type: full_time
• Salary: {'min': 100000.0, 'max': 140000.0, 'period': 'annual', 'currency': 'USD'}

Cambridge

• Skills: clinical data management, FDA regulations, CDISC standards, data deliverables, CRO management, eCRF specifications, data quality, risk mitigation, audit readiness, Medidata Rave
• Type: full_time
• Salary: {'min': None, 'max': None, 'period': '', 'currency': ''}

Boston

• Skills: clinical support, procedure training, clinical research, data collection, medical devices, cardiovascular experience, Good Clinical Practice, sales support, interventional procedures, regulatory compliance
• Type: other
• Salary: {'min': None, 'max': None, 'period': '', 'currency': ''}