Experience auditing quality systems, internal controls, and process improvements; strong analytical, communication, and problem‑solving skills; ability to prepare reports and assess risks.
RASIRC: Generates high-purity chemical vapors for semiconductor manufacturing.
6+ YOEBachelors in chemistry, chemical or mechanical engineering; 6+ years in regulated manufacturing supporting ISO 9001/QMS, audits, documentation control, CAPA, and project coordination; ability to work in cleanroom, lift 35 lbs, and follow safety protocols.
Outset MedicalNASDAQ: OM: Develops a portable dialysis system for clinical and home use.
3+ YOEBachelor's in engineering, medical, or science; minimum 3 years in quality systems within regulated environments; medical device experience; leadership skills; fluent English.
EPC Power: Designs and manufactures high-performance utility-scale power conversion inverters.
7+ YOE7+ years quality engineering in electromechanical or power electronics manufacturing; experience with quality management systems, VDA 6.3, Lean/Six Sigma, structured problem solving, product validation, reliability, and failure analysis.
VDA 6.3, Eight Disciplines Problem Solving, A3 Problem Solving Methodology, Root Cause Analysis, Human Error Root Cause Analysis, Lean Manufacturing, Six Sigma
One Stop SystemsNASDAQ: OSS: Designs high-performance rugged computing and storage for edge applications.
3+ YOE3+ years quality/inspection experience in manufacturing, AS9100/ISO9001 knowledge, ability to perform inspections, root-cause analysis, corrective actions, supplier quality, and use Excel/ERP systems.
Microsoft Excel, Microsoft Office, ERP/MRP, quality-management software
Auria: Engineering and software solutions for space and defense missions.
5+ YOE5+ years systems engineering, Bachelor's in engineering or related, active Secret clearance, 2+ years with Ground C2 systems, experience in project/configuration/quality management.
JTCW, TCS, GCCS, TSOA, CHE, CDN, JBC-P, MCH, VMware ESXi, Red Hat Enterprise Linux, Windows Server, Microsoft Active Directory, Cisco
Viking TherapeuticsNASDAQ: VKTX: Develops therapies for metabolic and endocrine disorders.
10+ YOE5+ MgmtBachelor's in life sciences or engineering, 10+ years QA experience with 5+ years in leadership; deep GMP/FDA/ICH knowledge, eQMS (Veeva) experience, QRM, audit and inspection readiness.
Protective Industrial Products (PIP): Global provider of personal protective equipment and safety products.
Industrial/Quality engineering; experience with quality systems ISO 9001 and IATF 16949; internal audits; quality tools (8D, CAPA, FMEA, SPC); English (intermediate/advanced); MS Office.
Quality management systems (ISO 9001, IATF 16949), 8D, CAPA, FMEA, SPC, Microsoft Office
Quality & Reliability Engineer (AI Systems & Workflow Assurance)
San Diego, California, United States
HybridFull Time
Clinically AI: Automates documentation and compliance for behavioral health providers.
3+ YOE3+ years in QA, software testing, or reliability engineering; automated testing with Playwright or similar; frontend debugging; API validation; JS/TS; CI/CD (GitHub Actions); strong root-cause analysis; collaborative in agile.
REVA Medical: Develops bioresorbable vascular scaffolds for treating artery disease.
Experience with ISO 13485 and FDA 21 CFR (820/210/211/Part 4), eQMS administration (Salesforce), SOPs, CAPA, audits, project management for software implementation, bachelor's in engineering or related, strong analytical and communication skills.
ASMLNASDAQ: ASML: Manufactures lithography systems used to print patterns on wafers.
5+ YOEBachelor's in engineering/CS, 5+ years testing embedded real-time software and algorithms for electro-mechanical systems, experience with test plan development, lab testing, oscilloscopes/logic analyzers, data analysis, and strong communication.
EatonNYSE: ETN: Manages electrical, hydraulic, and mechanical power systems globally.
6+ YOE6+ years quality systems experience with IATF 16949/ISO 9001 in automotive/aerospace, auditing, QMS operation, APQP/SPC/PPAP knowledge, Minitab and Six Sigma familiarity.
Surface Optics: Manufactures hyperspectral imaging systems and precision optical instruments.
Experience in design, modeling, analysis, calibration and testing of optical/electro-optical systems including radiometry, image quality metrics (MTF, MRTD, NIIRS, SNR), focal plane array analysis, and system integration.
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
ResMedNew York Stock Exchange: RMD: Developing cloud-connected medical devices for sleep and respiratory care.
Bachelor in engineering/science, experience with quality systems in medical or regulated industry, moderate audit experience, ability to manage CAPA and audit programs, knowledge of ISO13485 and FDA 21 CFR Part 820 preferred.
8+ YOEBachelor's in a relevant science/engineering field, 8+ years QA experience, 5+ years supplier management, injection molding/plastics experience, GMP knowledge, technical writing, electronic document systems experience, Microsoft Office/SAP proficiency.
DexcomNasdaq: DXCM: Manufacturer of continuous glucose monitoring systems for diabetes management.
5+ YOEEnsure software design assurance and regulatory compliance (IEC 62304, 21 CFR 820, ISO 13485, ISO 14971) for cloud, data, and AI/ML systems; perform risk management, author technical documentation, and support post‑market activities.