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.
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.
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.
Bothell or Cambridge or San Diego or Plymouth or Reedsville
$134k-$186k/yrHybridFull Time
PhilipsEuronext Amsterdam: PHIA: Manufactures medical imaging systems and personal care appliances.
5+ YOEBachelor's/Master's in engineering or science, 5+ years relevant experience with demonstrated leadership, mastery of quality systems/CAPA/FMEA, familiarity with medical device regulations (EU-MDR, 21CFR820), and ability to perform post-market risk assessment.
EU-MDR, 21CFR820, ISO 13485, ISO 14971/TS 24971, IEC 60601, IEC 62366, IEC 62304, IEC 60812/VDA FMEA Handbook, FMEA
Vertex PharmaceuticalsNASDAQ: VRTX: Develops and sells prescription drugs for serious genetic diseases.
15+ YOE7+ MgmtRequires 15 years relevant experience with 7 years supervisory leadership in a global organization; degree in life sciences; deep GxP (GMP/GCP) and QA oversight experience; strong regulatory/ICH knowledge; experience with QMS governance and change management; up to 15% travel.
Quality Management System (QMS), GxP, ICH, Lean, DMAIC, Six Sigma