Applied Medical: Manufacturer of advanced medical devices and surgical products.
Bachelor's in Engineering/STEM required (or related experience). Strong problem solving, root cause analysis, statistics, and communication. Working knowledge of Microsoft Office; ETQ Reliance experience preferred.
Microsoft Office, Microsoft Word, Microsoft Excel, Microsoft Outlook, ETQ Reliance
Mach Industries: Designs and manufactures autonomous unmanned aerial vehicles for defense.
5+ YOEBachelor’s in Engineering/Manufacturing/Quality; 5+ years in quality management in aerospace/defense; AS9100 knowledge; audit and CAPA; strong leadership.
AS9100, Quality Management System (QMS), CAPA, Nonconformance Reporting (NCR)
Karman Industries: Modular electric heat pumps for industrial thermal energy management.
5+ YOE5+ years in quality engineering; hands-on QMS ownership; working knowledge of ISO 9001 and audit process; experience with CAPA, RCA, and structured problem solving; ability to work autonomously.
Sanguine Biosciences: Provides in-home biospecimen collection for medical research studies.
8+ YOE3+ MgmtBachelor’s in biology/chemistry/life sciences or engineering; 8+ years quality support in clinical/pharma/biotech; 3+ years of people leadership; strong QMS, CSV, risk, CAPA, audits, and training experience.
Copy Of Senior R&D Engineer - Medical Device #8994
Marlborough or Irvine
OnsiteFull Time, Contract
ECI: Provides regulatory and engineering consulting for life sciences companies.
5+ YOEBachelor's in engineering (or equivalent experience), 5+ years R&D experience in medical device electromechanical products, strong quality and regulatory knowledge (FDA/ISO), proficiency with quality tools (SPC, DOE, FMEA, CAPA).
FujifilmTokyo Stock Exchange: 4901: Diversified manufacturer of healthcare, imaging, and semiconductor material products.
5+ YOEBachelor in Chemical Engineering or similar; 5-7 years in manufacturing/process engineering in a cGMP environment; GMP knowledge; bioprocessing equipment experience; strong communication; CAPA, change control; Lean/Six Sigma; English proficiency.
Quality Engineer III (SSO Division – Location: Irvine, CA)
Irvine, California, United States
$100k-$167k/yrOnsiteFull Time
Parker HannifinNYSE: PH: Manufacturer of motion and control technologies and systems.
5+ YOE5+ years quality experience with a Bachelor’s (or 3+ years with advanced degree). Strong QMS, audit, MRB/CAPA, supplier quality, and problem-solving skills; ISO/AS9100 knowledge and scheme auditor preferred; US citizenship required.
New World Medical: Develops and manufactures surgical devices for glaucoma treatment.
8+ YOEBachelor's in engineering/science required; 8+ years experience; certified auditor required; knowledge of ISO 13485, 21 CFR Part 820, GMPs, PPAP, CAPA, Gage R&R, DMAIC/Six Sigma and quality engineering/statistics.
ISO 13485, 21 CFR Part 820, GMPs, DMAIC, Six Sigma, PPAP, CAPA, Gage R&R, Process Audit, Equipment Validation
Giga Energy: Manufactures electrical infrastructure and operates modular AI data centers.
5+ YOE5+ years manufacturing engineering or supplier industrialization experience with metal enclosures, busbars, or switchboard assembly; SOPs, APQP/PPAP/FAI, SCAR/8D/CAPA, AQL; able to read schematics, GD&T, BOMs; comfortable working with Mexico contract manufacturers and traveling regularly.
Collectors: Providing authentication and grading services for high-value collectibles.
7+ YOE7+ years in quality management or quality-focused program management; hands-on with root cause analysis, CAPA, FMEA, SPC, Lean/Six Sigma; strong data analysis and dashboarding skills; ability to lead cross-functional programs; bachelor's degree in engineering/operations preferred; up to 20% travel and valid passport required.
Lean, Six Sigma, Kaizen, FMEA, CAPA, statistical process control, business intelligence (BI) tools
B. Braun: Develops and manufactures medical devices and pharmaceutical products globally.
2+ YOEBachelor's degree, 2+ years in quality/manufacturing/regulated environment, knowledge of GMP and CAPA, strong analytical and technical writing skills.
Koch Inc.: Operates global manufacturing, refining, and industrial technology businesses.
5+ YOE2+ Mgmt5+ years QA in manufacturing, 2+ years leading teams, experience with audits/inspections, risk analysis and CAPA, strong analytical and technical writing skills.
Pro-DexNASDAQ: PDEX: Designing and manufacturing precision medical device components.
0+ YOEMaintain and process nonconforming materials, perform root cause analysis and CAPA/SCAR, inspect product, analyze statistical data, and support MRB and supplier quality activities.
Minitab, Microsoft Excel, Microsoft Access, M2M, CMM, vision systems, calipers, micrometers, gages, indicators
3+ YOEBachelor’s in technical field; 3+ years in Quality/Software Quality; SDLC knowledge; regulatory experience; CAPA and complaint handling; strong communication; MS Office proficiency.
SDLC, quality documentation systems, Microsoft Office
EnvistaNYSE: NVST: Manufactures and sells a comprehensive range of dental products.
10+ YOE5+ MgmtBachelor's in Engineering, 10+ years in regulated industry, 5+ years leading teams; expertise in design controls, supplier quality, validation, CAPA, audits, and digital quality systems.
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
Forma Life Sciences: Contract development and manufacturing for oral solid dosage pharmaceuticals.
5+ YOE5+ years QA experience in GMP manufacturing with batch record review/approval, deviation/CAPA management, knowledge of CFR/ICH/GMP, attention to detail, and strong written/verbal communication.