Boston ScientificNYSE: BSX: Developing and manufacturing innovative medical devices for less-invasive treatments.
Requires a bachelor's degree in engineering or a related technical discipline, quality engineering and quality systems knowledge, data analysis, problem-solving, communication, and cross-functional collaboration.
Northridge or California or Seattle or Washington or Boston or New York City or Los Angeles County or United States
$121k-$205k/yrOnsiteFull Time
MiniMed GroupNasdaq: MMED: A medical device developing insulin delivery systems and connected care solutions for people living with diabetes.
5+ YOEBaccalaureate degree with 7+ years (or advanced degree with 5+ years) in quality systems; experience with QMS, Change Management, CAPA, audits, and Microsoft Office; strong communication and prioritization skills.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint, Agile, Trackwise, Microsoft Teams, Microsoft Project, Power BI
ABCorp: Produces secure payment cards and provides additive manufacturing solutions.
5+ YOE5+ years in quality assurance/systems in regulated manufacturing; experience with CAPA, deviations, investigations, change and document control, audits, SOPs, root cause analysis, QMS/ERP, and strong written documentation and cross-functional collaboration.
Boston ScientificNYSE: BSX: Developer and manufacturer of innovative medical devices and therapies.
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, data analysis, problem-solving, communication, and cross-functional collaboration skills required.
Boston ScientificNYSE: BSX: Manufacturer of interventional medical devices and technologies.
Bachelor's degree in engineering or a related technical field; quality engineering, process controls, CAPA, root cause analysis, continuous improvement, data analysis, communication, and cross-functional collaboration skills required.
ElevateBio: Develops and manufactures cell and gene therapies.
12+ YOE12+ years biopharma experience with leadership in Quality Systems; Business System Owner experience in GxP; expertise with eQMS/DMS/LMS/SAP/LIMS/MES; Veeva Vault preferred; familiarity with AI/ML, data integrity, CSV/CSA, and digital transformation.
Northeast Foods: A bakery focused on producing high-quality, safe, and compliant baked products.
Perform SPC data collection and analysis, product testing (pH, TTA, moisture, scoring), support HACCP/GMP sanitation, lift up to 50 lbs, stand long periods, and use Word/Excel/Outlook/PowerPoint.
SPC, HACCP, GMP, Microsoft Word, Microsoft Excel, Microsoft Outlook, Microsoft PowerPoint
Kymera TherapeuticsNASDAQ: KYMR: Develops targeted protein degradation medicines to treat human diseases.
5+ YOEBachelor's in life sciences, 5+ years quality systems/GxP/document control experience in a sponsor organization, hands-on eQMS administration, GxP training program management, knowledge of 21 CFR Part 11 and ICH E6(R3).
Veeva Vault, Microsoft Word, Microsoft Excel, Microsoft PowerPoint
Dyne TherapeuticsNASDAQ: DYN: Developing therapeutics for genetically driven neuromuscular diseases.
8+ YOE8+ years in biotech/pharma with QMS ownership; bachelor’s in scientific discipline or quality systems; expertise with GxP, eQMS (Veeva, MasterControl), eDMS/LMS, strong strategic, communication, and risk-management skills.
TE ConnectivityNYSE: TEL: Manufacturer of electronic connectors and sensors for global industries.
5+ YOEBachelor's in engineering/science or related, 5+ years related experience, ISO 13485 knowledge, audit and CAPA experience, eQMS experience, strong investigation and communication skills.
6+ YOEBS in a scientific discipline and 6+ years in quality roles; expertise with QMS, electronic document systems, vendor management, cGMP, ICH Q10 and FDA CFRs; experience with biologics and gene therapy products.
Stoke TherapeuticsNASDAQ: STOK: Develops RNA-based therapies for severe genetic disorders.
10+ YOEBS/BA in life sciences or chemistry,10+ years in biotech/pharma quality, QMS and computerized quality systems experience, strong FDA/EU/ICH GMP knowledge, Lean/Six Sigma experience, inspection/audit experience.
Integra LifeSciencesNASDAQ: IART: Manufacturing surgical instruments and regenerative medical technology devices.
18+ MgmtBachelor's degree required; master's preferred. Requires 18+ years leading teams, regulated-industry experience, medical device quality expertise, FDA and international regulatory knowledge, and change-management skills.
CAPA, Six Sigma, FDA Part 820, ISO 13485, CMDR, MDR, MDSAP, JPAL
Worthington EnterprisesNYSE: WOR: Manufactures pressure cylinders, steel products, and building materials.
3+ YOE3-5 years of quality engineering experience; knowledge of FMEA, internal audits, DOE, PPAP; skilled in statistics and quality systems; CQ Technician/Engineer or Auditor certifications preferred.
FMEA, Statistical software, MS Office, PPAP, DOE, Quality systems
WHOOP: Wearable technology for personalized health and performance tracking.
2+ YOEBachelor's in engineering or life sciences,2+ years QMS/QA experience in medical device or digital health,working knowledge of ISO 13485 and 21 CFR Part 820,QMS processes (CAPA,complaints,audits),and eQMS experience.
Director/Associate Director, Quality Management Systems
Norwood, Massachusetts, United States
HybridFull Time
Corbus PharmaceuticalsNASDAQ: CRBP: Develops clinical-stage therapies for oncology and obesity treatment.
10+ YOELife science degree or equivalent experience, 10+ years in GxP biotechnology or pharmaceuticals, eQMS expertise, regulatory knowledge, inspection leadership, project management, and English fluency.
Veeva, Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft PowerPoint, eQMS, Standard Operating Procedures (SOPs)
Draper: Designs and develops advanced guidance and navigation technologies.
Enrollment in an accredited science, technology, or engineering undergraduate or graduate program; strong communication, computer, troubleshooting, reasoning, and teamwork skills; U.S. citizenship required.
Microsoft Word, Microsoft PowerPoint, Microsoft Excel, C, C#, Python, Power BI, JIRA, Confluence
Verily: Developing data-driven technologies for clinical research and precision health.
8+ YOEBachelor's plus 8+ years in quality/regulatory for medical device or digital health, ISO 13485 and FDA QMSR experience, CAPA/risk management per ISO 14971, IEC 62304, SaMD/AI/ML quality experience, QMS leadership and team development.
Raynham or West Chester or Palm Beach Gardens or Warsaw or Raritan
$102k-$204k/yrHybridFull Time
Johnson & JohnsonNYSE: JNJ: Provides pharmaceutical products and medical technology healthcare solutions.
10+ YOEBachelor's in IT/CS/Engineering required, 10+ years in IT or digital quality, experience leading teams, system validation/compliance, AI/ML or advanced analytics experience preferred, Lean/Six Sigma certifications preferred, English required.