MiniMed GroupNasdaq: MMED: A focused on developing insulin delivery systems and connected diabetes care to improve daily life for people with diabetes.
5+ YOEBachelor's degree with 7+ years (or advanced degree with 5+ years) in medical device/pharma quality, 3+ years CAPA experience, audit support, regulatory knowledge, and CAPA system experience.
Space Kinetic: Developing propellant-free systems for deploying payloads in space.
3+ YOEBachelor's in Engineering, 3+ years in aerospace or regulated manufacturing, working knowledge of AS9100D/AS9102, inspection methods, GD&T, CAPA, and root cause analysis.
AS9100D, AS9102, GD&T, CAPA, NIST SP 800-171, CMMC, ITAR, ERP, QMS, electronic document control systems
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
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.
Salient Motion: Develops modular electromechanical actuation systems for aerospace and defense.
5+ YOEU.S. Person required; bachelor's in engineering or technical field (or equivalent); 5+ years quality experience in aerospace/defense or regulated manufacturing; hands-on AS9100 QMS, audits, CAPA, MRB, and AS9102 FAI experience.
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.
ProcessHQ: Provides vertically integrated bioprocess manufacturing solutions and equipment.
5+ YOE3+ Mgmt5+ years in pharmaceutical/biotech regulated industries, 3+ years QA/QC management, experience with CAPA, investigations, validation, audits, cGMP/GDP and ISO 9001 QMS, Bachelor's in a scientific discipline required.
ISO 9001-2015, Quality Management Systems (QMS), cGMP, GDP, CAPA
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.
Grand Prairie or Dallas or Charlotte or Pittsburgh or Seattle or Atlanta or Sylmar
HybridFull Time
PPGNYSE: PPG: Manufacturer of paints, coatings, and specialty materials.
8+ YOE5+ MgmtBachelor's in engineering,8+ years quality experience in aerospace/regulated manufacturing,5+ years supplier quality leadership,knowledge of AS9100/AS9145/APQP/PPAP/AS9102/CAPA/8D/FMEA/MSA/SPC,Lead Auditor preferred.
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
SaniSure: Designs and manufactures single-use bioprocessing and fluid management systems.
5+ YOEBachelor's in engineering, 5+ years manufacturing engineering in regulated (medical device/pharma) environments; Lean Six Sigma, process validation (IQ/OQ/PQ), pFMEA, SPC/Cpk, CAPA/NCR, DOE, CAD proficiency; ability to travel up to 10%.
Lean Six Sigma, SPC, Cpk, Gage R&R, IQ/OQ/PQ, pFMEA, CAPA, NCR, CAD, Design of Experiments (DOE)
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