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.
VulcanForms: Provides industrial-scale metal additive manufacturing and precision machining services.
3+ YOE3+ years in medical device or aerospace quality with knowledge of FDA requirements, ISO 13485/AS9100/ISO9001, QMS, CAPA, NCR, document control, procedure writing, audits, and quality metrics/KPIs.
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.
Sirtex Medical: Manufactures targeted radiation therapies for inoperable liver cancer patients.
5+ YOEBachelor's in engineering/life sciences required, 5+ years quality systems experience in medical device/pharma/biotech, proven eQMS administration (Veeva, MasterControl, ETQ, TrackWise), and strong knowledge of 21 CFR Part 820, ISO 13485, MDSAP.
Veeva Vault, MasterControl, ETQ, TrackWise, eQMS, Power BI, Tableau, Microsoft Excel
Rochester Electronics: Licensed semiconductor manufacturer and distributor for end-of-life components.
10+ YOE5+ MgmtBachelor's degree in engineering or related field, 10 years quality management experience, 5+ years supervisory experience, semiconductor manufacturing experience, knowledge of ISO9000/IATF16949/AS9100/JEDEC, SPC/LEAN/6 Sigma, auditing and strong computer and communication skills.
Berkshire Sterile Manufacturing: Sterile drug filling and formulation for clinical and commercial use.
10+ YOE5+ MgmtLead the Quality Systems division ensuring cGMP compliance; oversee QA processes, regulatory submissions, and client/gov inspections; 10+ years pharma quality with 5+ in leadership; BS in science, MS preferred; auditor certification preferred.
Access Vascular: Develops biomaterial catheters that reduce clinical complications during intravenous therapy.
5+ YOEBachelor's in Engineering or Life Sciences; 5+ years quality systems in medical devices; QMS experience (FDA 21 CFR Part 820, ISO 13485); CAPA, document control, audits; CQE/CMDA or ISO Lead Auditor a plus.
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.
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.
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.
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.
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
3+ YOEBachelor's degree or equivalent; 3+ years in manufacturing; strong MS Office; SQL/Reporting; QA data analysis; ability to travel; regulatory experience preferred.
Microsoft Office, SAP, InfoMed, SQL Server, Reporting Services
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
3+ YOEBachelor's degree or equivalent; minimum 3 years in manufacturing; strong MS Office; experience with automated databases; SQL knowledge; SAP/InfoMed experience preferred; ability to travel.
Microsoft Office, SQL Server, Reporting Services, Analysis Services, SAP, InfoMed, MS SQL, Automated databases
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