Last updated: 2025-05-22

43 Quality Assurance And Engineering jobs in Raleigh.

Hiring now: Regulatory Engr @ Onlogic, Regulatory Affairs Spec M @ Intuitive , Manufacturing Tech 2 Line @ Biomérieux, Manufacturing And Quality @ Beam, Spec Sr Spec @ Beam Thera, Validation Area Spec @ Novo Nordi, Associate Dir Of Global R @ Grail, Front Line Manufacturing @ Amgen, Rd Lab Tech @ Teleflex, Mgr Software Systems Eng @ Baxter.Explore more at at kaamvaam.com

🔥 Skills

project management (10) compliance (9) manufacturing (8) regulatory compliance (7) SOPs (7) GMP (6) quality (5) Compliance (4) medical device (4) medical devices (4)

📍 Locations

Raleigh (20) Durham (9) Chapel Hill (4) Morrisville (4) Sanford (3) Holly Springs (2) Cary (1)
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Onlogic

Regulatory Engineer Cary
Skills & Focus: Regulatory Engineering, Product Safety, EMC, Testing, Compliance, Cross-functional collaboration, Problem-solving, Document management, Product Safety Standards, Interdisciplinary team
About the Company: OnLogic is growing, and we want to give you the same opportunity to grow in your career! We design and manufacture specialized computers and hardware solutions…
Experience: Minimum of 10 years of regulatory engineering experience.
Salary: $110,000 to $140,000
Type: Full-time
Benefits: Comprehensive benefits package including 401k Plan with 3% Employer Contribution, Annual Profit Share Bonus, Paid Mater…

Intuitive Surgical

Regulatory Affairs Specialist – Mandarin Speaking Chapel Hill
Skills & Focus: regulatory affairs, NMPA, medical device, product registration, regulatory compliance, project management, team collaboration, regulatory submissions, clinical strategy, product lifecycle
About the Company: A pioneer and market leader in robotic-assisted surgery, committed to advancing minimally invasive care through innovative technology.
Experience: Minimum 3 years RA experience, 1 year NMPA requirements
Type: Full-time
Benefits: Comprehensive healthcare, professional development, family support, and equity opportunities
Head of Clinical Research Engineering Chapel Hill
Skills & Focus: clinical research, engineering leadership, medical devices, robotic systems, clinical studies, product development, regulatory compliance, patient safety, prototype evaluation, team management
About the Company: At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, w…
Experience: 10+ years in medical device development, 5+ years in leadership
Type: Full-time
Project Coordinator Chapel Hill
Skills & Focus: Project Management, Product Development, Cross-functional Collaboration, Risk Management, Design Control, Regulatory Submissions, Milestone Tracking, Quality Systems, Medical Devices, Process Improvement
About the Company: At Intuitive, we are committed to minimally invasive care through innovative robotic-assisted surgery technology. We foster an inclusive and diverse team dedic…

Biomérieux

Manufacturing Tech 2, Line 4 - Night Shift Durham
Skills & Focus: production, packaging, cGMP, manufacturing, SOP, FDA regulations, OSHA regulations, high-speed equipment, quality control, safety
About the Company: bioMérieux is a multinational biotechnology company that develops and produces in vitro diagnostic solutions for various medical purposes.
Experience: 2+ years of relevant experience in a regulated production/operations environment, OR Equivalent military experience
Type: Full-time
Benefits: Low-cost medical, dental, and vision benefits starting day one, 11 paid holidays, 160 hours of paid time off, Annual bo…
Manufacturing Tech 2, Line 4 - Day Shift (C) Durham
Skills & Focus: production, equipment, operation, SOP, GMP, quality, validation, manufacturing, safety, records
Manufacturing Tech 1, Service - Night Shift (B) Durham
Skills & Focus: manufacturing, equipment operation, cGMP compliant, production activities, quality assurance, SOP, safety compliance, biotechnology, bioworks, FDA regulations
About the Company: bioMérieux is a global biotechnology company that develops and supplies diagnostic solutions for infectious diseases and health management.
Experience: 0 years of experience required
Salary: $19.25 - $20.00/hr
Type: Full-time
Benefits: Low-cost medical, dental, and vision benefits starting day one; 11 paid holidays; 160 hours of paid time off; Annual bo…

Beam

Manufacturing and Quality Professionals Durham
Skills & Focus: Manufacturing, Quality, facility, innovators, collaborative environment, patients, impact, state-of-the-art, team, RTP
About the Company: Beam is preparing to open a state-of-the-art Manufacturing facility located on Davis Drive in RTP, NC, focused on helping patients and fostering a collaborativ…
Type: Full-time

Beam Therapeutics

Specialist / Senior Specialist Durham
Skills & Focus: Quality Management System (QMS), GxP compliance, Change Management, cGMP regulations, Continuous Improvement, Quality Event KPIs, SOPs, technical writing, regulatory inspections, Supplier Qualification
About the Company: Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this …
Experience: 10+ years’ experience in the pharmaceutical/biotech industry with 2+ years’ experience working with Quality Management Systems
Type: Full-time

Biomérieux

Regulatory and Quality Compliance Expert Durham
Skills & Focus: regulatory compliance, quality procedures, vigilance reporting, adverse event reporting, medical device, project management, cross-functional team, SOPs, audit, continuous improvement
Experience: 7+ years in regulatory affairs or equivalent regulated industry employment position, medical device/IVD industry preferred

Novo Nordisk

Validation Area Specialist Durham
Skills & Focus: validation, pharmaceutical, compliance, quality, engineering, risk-based, revalidation, investigations, root cause analysis, cGMP
About the Company: Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes and obesity. They operate pharmaceutica…
Experience: Minimum of five (5) years of validation related discipline experience in pharmaceutical or medical device industry required.
Benefits: Leading pay and annual performance bonus, generous paid time off including 14 paid holidays, health insurance, dental i…

Grail

Associate Director of Global Regulatory Affairs & Safety Durham
Skills & Focus: Global Regulatory Affairs, Safety, IVD product registrations, MHRA, Notified Bodies, promotional material, on-market product support, UKRP audits, regulatory requirements, cross-functional stakeholders
About the Company: GRAIL is a healthcare company, pioneering new technologies to advance early cancer detection. We are using the power of next-generation sequencing (NGS), popul…

Beam Therapeutics

Sr/Principal CQV Engineer Durham
Skills & Focus: CQV program, internal manufacturing, testing operations, regulatory compliance, capital projects, continuous improvement, validation package, GMP facilities, project management, team leadership
About the Company: Beam Therapeutics is a clinical stage biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. B…
Experience: 12+ years in the biopharmaceutical/biotech industry supporting internal manufacturing and testing operations

Amgen

Front Line Manufacturing Manager (Downstream) - Night shift Holly Springs
Skills & Focus: manufacturing, operations, compliance, cGMP, leadership, continuous improvement, training, safety, team performance, biotechnology
About the Company: Through its focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– Amgen has helped pioneer the world of biotech since 19…
Experience: 12 years of Manufacturing or Operations experience
Salary: 114,259.00 USD - 133,764.00 USD
Type: Full time
Benefits: Amgen offers an award-winning culture that is collaborative, innovative, and science-based.
Senior Manufacturing Systems Engineer: Automation Holly Springs
Skills & Focus: automation, engineering, GMP, manufacturing, system, integration, documentation, troubleshooting, commissioning, project management
About the Company: At Amgen, we're helping pioneer the world of biotech in our fight against the world's toughest diseases. Our mission is to serve patients living with serious i…
Experience: 4 years of Engineering experience
Salary: 142955.00 USD - 162947.00 USD
Type: Full time

Teleflex

R&D Lab Technician Morrisville
Skills & Focus: testing support, surgical medical devices, test documentation, data collection, process improvement, CAPAs, ISO testing methods, FDA, GMP, design control process
About the Company: Teleflex is a global provider of medical technologies, driven by a purpose to improve the health and quality of people’s lives with a diverse portfolio in area…
Experience: 2-5 years of experience in product testing (medical device preferred)
Type: Part-time
Quality Engineer 1, Product Quality Assurance Morrisville
Skills & Focus: Quality Assurance, medical device, product quality, root cause investigation, risk management, Quality Management Systems, nonconformances, statistical techniques, regulatory inspections, product metrics
About the Company: As a global provider of medical technologies, Teleflex is driven by our purpose to improve the health and quality of people’s lives. Through our vision to beco…
Experience: 0-2 years related (medical device preferred) experience
Process Manager, Marketing Communications Morrisville
Skills & Focus: marketing content, ECO system, cross-functional partners, content compliance, process optimization, project coordination, medical device, quality, document control, SOPs
About the Company: Teleflex is a global provider of medical technologies, driven by the purpose to improve the health and quality of people's lives. They offer a diverse portfoli…
Experience: Minimum of 5 years of experience in marketing or a related field.

Baxter

Manager, Software Systems Engineering Raleigh
Skills & Focus: infusion systems, software engineering, medical devices, Agile development, innovation, risk management, quality delivery, collaboration, mentoring, regulatory compliance
About the Company: Baxter’s Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients' needs globally. For over 85…
Experience: 8+ years of related experience in managing technical teams in the development of medical device software.
Salary: $128,000.00 to $176,000.00 annually
Type: Full-time
Benefits: Comprehensive compensation and benefits packages including medical and dental coverage, Employee Stock Purchase Plan (E…
Specialist, Asset Raleigh
Skills & Focus: healthcare, medical devices, patient care, innovation, R&D, manufacturing, diversity, inclusion, collaboration, technology
About the Company: Baxter International is a leading global medical products company, developing technologies that save and sustain lives. Our firm is dedicated to improving pati…
Type: Full time
Benefits: Comprehensive benefits options reflecting the value placed in employees.
Principal Systems Engineer - Software Raleigh
Skills & Focus: Principal Systems Engineer, software, healthcare solutions, Infusion Pump Platforms, cross-functional, risk analysis, verification engineers, agile, test strategies, regulatory standards
About the Company: Baxter's Research and Development teams work cross functionally to innovate, develop and introduce creative solutions for patients needs globally. For over 85 …
Experience: 5+ years of experience
Salary: $112,000 to $154,000 annually
Type: Full-time
Benefits: Comprehensive compensation and benefits packages including medical, dental, and employee stock purchase programs.

Project Farma

Consultant, Project Controls Engineering Raleigh
Skills & Focus: Project Controls, Engineering, Biomanufacturing, Budget Estimates, Project Schedules, Risk Analysis, Cost Reports, Client Engagement, Quality Compliance, Life Sciences
About the Company: Project Farma is the leading advanced therapy technical operations consulting company in the life science industry, committed to advancing manufacturing to ach…
Experience: Minimum 3 years of scheduling and/or project controls experience.
Salary: $50,000 - $240,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance effective you…

Baxter International

Software Verification Manager Raleigh
Skills & Focus: Software Verification, Engineering, Medical Devices, R&D, Product Security, Embedded Software, Electromechanical, Integration, Healthcare, Innovation
About the Company: Baxter International is a leading manufacturer of medical devices and solutions, focusing on innovative therapies and healthcare solutions for patients worldwi…
Type: Full Time
Benefits: Our comprehensive benefits options reflect the value we place in our employees.

Mallinckrodt

Quality Analyst II Raleigh
Skills & Focus: Quality Analyst, Product Release, Quality Metrics, GMP, Audits, Customer Inquiries, Batch Record Review, Label Preparation, CAPA, Change Control
Experience: 1-3 years pharmaceutical manufacturing experience preferred

Project Farma

Project Engineer Raleigh
Skills & Focus: biomanufacturing, project management, cell and gene therapy, capital projects, facility builds, tech transfers, validation life cycle, commissioning and qualification, quality, regulatory compliance
About the Company: Project Farma (PF) is the leading advanced therapy technical operations consulting company in the life science industry. We provide biomanufacturing strategy a…
Experience: 0-3 years of consulting and/or project engineer experience
Salary: Competitive salary based on experience
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance effective you…
CQV Engineering Consultant Raleigh
Skills & Focus: CQV Engineering, life science, Project Management, Validation Life Cycle, Project Engineer, technical documentation, process validation, client project initiatives, mentoring, philanthropy
About the Company: Project Farma is the leading advanced therapy technical operations consulting company in the life science industry. We are committed to advancing manufacturing…
Experience: A minimum of 3 years of Project Engineer, Consulting, and/or relevant industry experience.
Salary: $50,000 - $240,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance, 401k Plan wi…

Johnson & Johnson

Senior Manager External Quality Raleigh
Skills & Focus: Quality, Compliance, External Manufacturing, GMP, Quality Systems, Regulatory, Process Integration, Digital Solutions, Leadership, Supply Chain
About the Company: Global healthcare company specializing in innovative medicine and MedTech solutions, committed to health innovation and improving access and affordability.
Type: Full-time

Project Farma

Senior Project/Validation Engineer Raleigh
Skills & Focus: project management, validation, engineering, quality, compliance, consulting, manufacturing, technical documents, GxP, patient focused
About the Company: Project Farma is the leading advanced therapy technical operations consulting company in the life science industry, focused on advancing manufacturing to achie…
Experience: Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience.
Salary: $50,000 - $240,000 USD
Type: Full-time
Benefits: Competitive salary based on experience, Aggressive bonus structure, Medical, Dental, and Vision insurance, 401k Plan wi…

Sequoia Biotech Consulting And Syner-G Biopharma Group

Sr. Project Manager Raleigh
Skills & Focus: capital project execution, biologics manufacturing, drug substance, drug product, utilities infrastructure, GMP compliance, project budgets, design teams, construction, process integration
About the Company: Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences c…
Experience: 7–15 years in capital project management within biologics or life sciences manufacturing
Salary: $115,000 to $143,000
Type: Full-time
Benefits: Total Rewards Program includes compensation, benefits, remote work options, development, recognition, flexible paid tim…

Veeva Systems

Computer Software Validation (CSV) Professional Raleigh
Skills & Focus: computer software validation, clinical trial software, RTSM software, technical writing, validation process, project management, customer implementation, product excellence, lifesciences industry, remote work
About the Company: Veeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the…
Experience: Strong technical writing capabilities and expertise in clinical trial software validation
Type: Full-time
Benefits: Flexible work environment, remote work options (Work Anywhere policy)

Crb

CQV, Sr. Project Manager Raleigh
Skills & Focus: cGMP, CQV, project management, validation, compliance, risk assessments, specifications, technical training, stakeholder communication, system reviews
About the Company: CRB provides cGMP leadership and guidance for the integration and delivery of CQV services for Life Sciences clients.

Sequoia Biotech Consulting

Process Engineer Raleigh
Skills & Focus: Process Engineer, drug substance manufacturing, SOPs, manufacturing batch records, FDA regulations, GMP practices, technical documentation, cross-functional team, manufacturing processes, compliance
About the Company: Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences c…
Experience: 5-7 years
Salary: $107,000 to $130,000
Type: Full-time
Benefits: Market competitive salary, annual incentive plan, robust benefit offerings, generous flexible paid time off program, co…

M3 Wake Research

Quality Assurance Specialist Raleigh
Skills & Focus: quality assurance, clinical trials, SOPs, compliance, audits, process improvement, training, CAPA plans, regulatory inspections, clinical research

Primevigilance

Client Quality Officer Raleigh
Skills & Focus: quality management, training, compliance, Pharmacovigilance, SOPs, audit, client projects, performance metrics, risk assessment, deviations

Cai

CQV Engineer Raleigh
Skills & Focus: Commissioning, Qualification, Validation, pharmaceutical facilities, protocol writing, regulatory industry, utilities, project management, troubleshooting, document development
About the Company: CAI is a 100% employee-owned company established in 1996 that has grown to more than 800 people worldwide. We provide commissioning, qualification, validation,…
Experience: 2-4 years' experience in commissioning and qualification in a regulated industry
Salary: Not specified in job posting
Type: Full-time
Benefits: Competitive compensation and benefits which include: up to 15% retirement contribution, 24 days PTO and 5 sick days per…

Precision For Medicine, Manufacturing Solutions

Client Support Engineer Raleigh
Skills & Focus: technical documents, SOPs, requirements specifications, testing protocols, GxP best practices, system validation, engineering life cycle, project deliverables, problem-solving, cross-functional team alignment
About the Company: The leading advanced therapy technical operations consulting company in the life science industry, committed to advancing manufacturing to achieve operational …
Experience: Bachelor’s degree in Life Science, Engineering, or related discipline and/or comparable military experience.
Salary: $58,000 – $63,000 USD
Type: Full-time
Benefits: Competitive salary, Aggressive bonus structure, Medical, Dental, and Vision insurance, 401k Plan with company match, Pa…

Crb

Automation Project Manager Raleigh
Skills & Focus: Automation, Project Management, Life Sciences, Integration, Delivery, Design, Validation, Compliance, Engineering, Construction

Kyowa Kirin North America

IT Specialist - QC, LIMS Sanford
Skills & Focus: LIMS, compliance, system administration, technical support, GxP, quality operations, SDLC, ITIL, project management, troubleshooting
About the Company: Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in …
Experience: At least 3 years of hands-on IT support experience, including troubleshooting complex issues, system management, and working directly with end-users and business partners.
Type: Full-time
Sr Specialist, Quality Control-Microbiology Sanford
Skills & Focus: Quality Control, Microbiology, GxP, Biopharmaceutical, Compliance, Laboratory, Technical Leadership, Contamination, Investigation, Environmental Monitoring
About the Company: Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in …
Experience: At least 5 years of experience in Quality Control Microbiology laboratory providing technical and compliance leadership within GxP Biopharmaceutical Manufacturing operations.
Senior Automation Engineer Sanford
Skills & Focus: automation engineer, biopharma, SCADA, PLC, GMP, Data Integrity, manufacturing systems, process systems, technical skills, collaborative environment
About the Company: Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines.
Experience: Minimum 5 years of experience as an automation engineer in the pharmaceutical, biopharma, and/or life sciences industries.
Type: Full-time