BiVACOR: Developing an advanced total artificial heart for patients.
18+ YOEBachelor’s in Electrical Engineering; 18+ years in medical device quality leadership; deep knowledge of Class III AIMD; FDA IDE/PMA; IPC-A-610/IPC-A-620 preferred.
FMEA, FT A, statistical_analysis, MSA/Gage R&R, QMS software, ISO 14971, IEC 60601, ISO 13485, 21 CFR Part 820/803/806
MoogNYSE: MOG.A: Design and manufacture of precision motion control systems.
3+ YOEBachelor's in engineering, 3+ years engineering experience with 2+ years in quality engineering in manufacturing; knowledge of AS9100, audit support, statistical analysis, and mechanical/electro-mechanical hardware.
Edwards LifesciencesNYSE: EW: Designs and manufactures medical devices for structural heart disease.
Bachelor's in engineering or science, experience in quality engineering/regulatory compliance within medical device industry, knowledge of FDA/GMP/ISO, team leadership and product development experience.
Sift: Software platform for high-frequency hardware telemetry observability.
8+ YOE3+ Mgmt8+ years in QA with senior quality leadership, 3+ years people management, experience with external QA vendors, strong test planning/regression/triage and frontend/backend testing, AI-forward QA approach, strong communication.
MicroVention: Manufacturer of neurovascular medical devices for stroke treatment.
4+ YOEBachelor's in engineering, 4+ years quality or manufacturing engineering in medical device/regulated manufacturing; experience with CAPA/NCR, validation, FMEA, IQ/OQ, audits, and statistical analysis; strong communication and MS Office/MiniTab skills.
Microsoft Word, Microsoft Excel, Microsoft Teams, Microsoft Outlook, MiniTab
Premarket Quality Engineering Director (ICT), Santa Ana, CA
Santa Ana, California, United States
$198k-$298k/yrOnsiteFull Time
MedtronicNYSE: MDT: Developing and manufacturing medical technologies and therapies globally.
10+ YOE7+ MgmtBachelor's degree, ~10 years relevant experience with 7+ years managerial experience; expertise in design controls, risk management, product development quality and program leadership.
Premarket Quality Engineering Director (ICT), Santa Ana, CA
Santa Ana, California, United States
$198k-$298k/yrOnsiteFull Time
MedtronicNew York Stock Exchange: MDT: Develops and manufactures medical devices and digital health solutions.
10+ YOE7+ MgmtBachelors degree and ~10 years relevant experience with 7+ years managing teams; expertise in design controls, risk management, program execution, and regulatory compliance.
Brio Water Technology: A manufacturer of water refrigeration and ice production products focused on delivering hydration solutions and improving customer experience.
3+ YOEBachelor's in engineering, 3+ years quality engineering in manufacturing, ISO 9001 knowledge, RCA and CAPA experience, FMEA/SPC/MSA/PPAP proficiency, GD&T and precision measurement experience, ERP/MES and quality software familiarity.
Rangeview: Operates an automated foundry producing precision metal aerospace parts.
7+ YOE5+ MgmtABET-accredited engineering degree,7+ years manufacturing/quality experience,5+ years managing engineers or quality teams,experience with AS9100/ISO9001/NADCAP preferred,knowledge of production quality,root-cause analysis,and regulatory requirements.
Quantic Electronics: Manufacturer of mission-critical electronic components and systems.
5+ YOEBachelor's in engineering/quality or related; 5+ years in quality leadership in manufacturing; experience with ISO 9001, audits, 8D/CAPA/FMEA/SPC; quality certifications preferred.
ISO 9001, 8D, CAPA, FMEA, SPC, IPC Standards, Microsoft Office
Luxfer Gas CylindersNYSE: LXFR: Manufacturer of high-pressure aluminum and composite gas cylinders.
3+ YOEEnsure product quality and AS9100/ISO9001 compliance, lead audits, perform root cause analysis and supplier quality activities; 3+ years quality engineering experience and bachelor\u000bdegree in engineering preferred.
AS9100, ISO 9001, FMEA, Root Cause Analysis, PPAP, SPC, CAPA, ERP, MRP, Minitab
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
2+ YOE0-2 years of related experience; bachelor’s in science/engineering; basic quality systems knowledge; able to work in a quality environment; familiarity with FMEAs and design controls; potential manufacturing experience preferred.
Pioneer Circuits: Leading private U.S. manufacturer of high-performance flexible circuit boards.
2+ YOEBachelor's in Materials Science or Chemical Engineering; 2+ years in PCB quality; ISO 9001/AS9100; Six Sigma/LEAN; strong analytical, documentation, and communication.
Koch Inc.: Operates global manufacturing, refining, and industrial technology businesses.
4+ YOEProvide technical leadership in quality for regulated manufacturing: lead root cause investigations, support QMS/APQP, use statistical tools, manage supplier quality; bachelor\u0002s in engineering or 4+ years quality engineering experience, FDA/regulatory experience valued.
Anduril Industries: Defense technology building autonomous military hardware and software.
8+ YOE8+ years quality engineering in regulated manufacturing (aerospace/defense), experience with AS9100 QMS, AS9102 FAIs, GD&T, root cause analysis (8D, 5 Whys), FMEA, supplier qualification; BS in engineering or equivalent; eligible for U.S. Secret clearance.
Precision Castparts Corp.NYSE: BRK.B: Manufacturer of complex metal components for aerospace and industrial markets.
2+ YOEBachelor's in engineering, typically 2+ years manufacturing/quality experience (aerospace preferred). Proficient with SPC, Microsoft applications, lean fundamentals, troubleshooting, audits, and quality systems.
statistical process control (SPC), Microsoft applications
HenkelXETRA: HEN3: Manufactures laundry, beauty, and adhesive products globally.
Quality control testing of materials and finished goods; SAP data entry; SHEQ compliance; sample management; support for Quality Engineers; process optimization; project execution; develop tests and report data; coordinate regulation changes.