RoslinCT: Contract manufacturing for advanced cell and gene therapies.
8+ YOE8+ years QA experience in GMP environments, 3+ years validation QA, knowledge of GAMP, cGMP, ICH, 21 CFR Part 11/Annex 11, ability to review validation deliverables and support investigations.
RedwireNYSE: RDW: Manufactures infrastructure and hardware components for diverse space missions.
2+ YOEAerospace QA experience in manufacturing, 2+ years QA/manufacturing experience desired, knowledge of AS9100/ISO9001, J-STD-001/NASA 8739 standards, inspection and root-cause analysis, ITAR/US person eligibility required.
TScan TherapeuticsNasdaq: TCRX: Developing T-cell receptor-based therapies for cancer and autoimmune diseases.
10+ YOE3+ MgmtBS in a scientific discipline,10+ years biotech/pharma experience with ≥3 years in aseptic GMP manufacturing and QA; proven inspection experience, cGMP/21 CFR/ICH knowledge, supervisory experience, strong communication and data analysis skills.
Dyne TherapeuticsNASDAQ: DYN: Developing therapeutics for genetically driven neuromuscular diseases.
6+ YOEBachelor's in engineering/science (Master's preferred), 6+ years cGMP experience, 4+ years QA experience, knowledge of FDA/EMA regulations, GxP QA systems, CAPA, investigations, and proficiency with MS Office, SmartSheet, and Veeva.
BroadcomNASDAQ: AVGO: Designs and sells semiconductors and infrastructure software to enterprises.
5+ YOE5+ years in mainframe software development; IBM Assembler on z/OS; Endevor/GitHub; Agile experience; SQL on mainframe databases; QA/DevOps familiarity.
7+ YOE7+ years leading QA vision for complex SaaS and on-prem products; experience with autonomous agent fleets, AI-first testing, E2E frameworks, MEAN stack, CI/CD pipeline optimization; strong communication and mentoring skills.
Principal Engineer, Design Quality - Software (Westborough, MA, US, 01581)
Westborough, Massachusetts, United States
$120k-$168k/yrRemoteFull Time
OlympusTokyo Stock Exchange: 7733: Manufactures medical endoscopes and minimally invasive surgical tools.
9+ YOELead software quality and regulatory compliance for medical device software; 9+ years in software/QA; BS in engineering; travel up to 15%; fluent in English.
Regulatory standards: IEC 62304, Regulatory standards: IEC 82304, Regulatory standards: ISO 14971, Regulatory standards: ISO 13485, Regulatory standards: ISO 81001-2, Regulatory standards: ISO 81001-5-1, Regulatory standards: AAMI TIR34971
NordsonNasdaq: NDSN: Manufactures precision dispensing and fluid management equipment for industry.
2+ YOEBachelor’s degree in engineering; 2-3 years QA; proficient in MS Office; ISO9000 manufacturing experience; strong problem-solving skills; knowledge in statistics, QA tools, and design of experiments.
ECI: Provides regulatory and engineering consulting for life sciences companies.
10+ YOEStrong knowledge of ISO 9001; QA terminology, methods and tools; analytical, problem-solving and decision-making skills; experience with QA practices, audits and defect management.
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
4+ YOEBachelor's in engineering or equivalent, 4+ years packaging experience in regulated environment, packaging qualification/testing and validation experience, knowledge of ISO13485/ISO11607/ISTA/ASTM, DOE and QA methods.
EmersonNYSE: EMR: Engineering industrial automation and software solutions for global industries.
2+ YOE2+ years quality/QA engineering experience, proficiency with Microsoft Office, ability to conduct audits, analyze data, and maintain quality records; legal US work authorization required.
$115k-$135k/yrHybridMultiple Commitments Available
GetingeNasdaq Stockholm: GETI B: Manufactures medical equipment for acute care and life sciences.
5+ YOEBachelor's in science/engineering, 5+ years quality/manufacturing experience in GMP environments, experience with new product introduction, ETQ Reliance and Microsoft Office proficiency, cleanroom experience, problem-solving and QA skills.
CGINYSE: GIB: Provides information technology and business consulting services.
6+ YOE6+ years QA test automation engineering experience building API and UI automation using Karate/RestAssured and Playwright/Cypress; strong Java/JavaScript/TypeScript skills; CI/CD and SQL experience.
MBRAUN: Manufacturer of high-end controlled environment systems and gloveboxes.
Experience supporting NQA-1/QAR projects, familiarity with ASTM/ASME/ANSI/AWS/ISO/DIN standards, ability to perform supplier audits/CGD surveys, compose and approve QA documentation, and liaise with engineering/production/customers.
RTXNYSE: RTX: RTX provides advanced aerospace and defense systems and services.
5+ YOESTEM degree with 5+ years experience or advanced degree with 3+ years; active DoD Secret clearance; software test experience in DoD contexts; travel may be required.
Commonwealth of Massachusetts: Providing public services and governance to the people of Massachusetts.
6+ YOE2+ MgmtSenior leadership role requiring development and maintenance of quality management, compliance, internal audits, and document control; minimum 6 years professional experience with 2 years supervisory experience.