Quality Operations Program Manager - Document Control
Pleasanton, California, United States
$100k-$150k/yrRemoteFull Time
Veeva SystemsNYSE: VEEV: Cloud-based software solutions for the global life sciences industry.
5+ YOEBS/BA or equivalent experience, 5+ years in regulated quality role, experience with QMS/eDMS/eQMS, knowledge of GxP and 21CFR11, strong process mapping and communication skills.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
12+ YOEBachelor's degree,12+ years healthcare regulatory/compliance and quality systems experience with people leadership; experience with QMS,CAPA,Joint Commission,CMS,state licensing; strong analytical and communication skills.
Director, Quality Management Systems (Athlone, L, IE)
Athlone or Morrisville or Pleasanton or Santa Barbara
OnsiteFull Time
TeleflexNYSE: TFX: Manufactures medical devices for critical care and surgical procedures.
Lead and maintain global QMS (ISO 13485, EU-MDR, MDSAP), manage eQMS integrations, support regulatory audits/inspections, lead CAPA and quality projects, manage teams, budgets and cross-functional stakeholders.
StandardAeroNYSE: SARO: Provides maintenance, repair, and overhaul services for aircraft engines.
3+ YOEBachelor's in quality/engineering/manufacturing/industrial technology (or equivalent experience), 3+ years QA experience, 3+ years conducting root cause and CAPA, QMS experience, ability to lift 25 lbs and remain stationary for inspections.
5 Whys, Fishbone, FMEA, Corrective and Preventive Actions (CAPA), Quality Management Systems (QMS), ISO 9001, AS9100, AS9110, FAA regulations, Lean Manufacturing, Six Sigma
AbbottNYSE: ABT: Provides medical devices, diagnostics, and science-based nutritional products.
10+ YOE5+ MgmtBS in Engineering,10+ years manufacturing/process development experience,5+ years managing technical staff,3+ years project management,knowledge of DOE/SPC/Lean,GMP/ISO/QMS compliance,ability to travel ~10%.
Applied Aerospace & Defense: Designs and manufactures mission-critical hardware for aerospace and defense.
5+ YOEBachelor's in engineering (aerospace/mechanical/manufacturing) with 5+ years experience preferred, knowledge of GD&T and QMS standards, technical writing ability, and Microsoft Office proficiency.
Microsoft Excel, Microsoft Word, Microsoft PowerPoint
Rocklin or Modesto or Merced or Menlo Park or Chico or Sacramento or Antioch or California or Washington or Oregon
$160k-$185k/yrFieldFull Time
Kalesta Healthcare Group: Operates skilled nursing and assisted living healthcare facilities.
3+ YOEActive California RN license, 3+ years as MDS Coordinator in an SNF, deep knowledge of RAI/PDPM/QMs, PCC proficiency preferred, and ability to travel frequently across Northern California.
AbbottNYSE: ABT: Manufactures medical devices, diagnostics, and nutritional health products.
10+ YOE5+ MgmtBS in Engineering required; 10 years manufacturing/process development experience, 5 years managing technical staff, 3 years project management; knowledge of DOE, SPC, Lean, GMP/ISO and FDA/QMS compliance.
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
10+ YOEBachelor's in Science/Engineering, 10+ years medical device industry experience, expert QMS knowledge (21 CFR Part 820, ISO 13485, MDSAP), multi-site quality operations, Lean/Six Sigma training, TrackWise/AGILE/E1/SAP/LIMS familiarity; travel up to 30%.
FerrotecTokyo Stock Exchange: 6890: Manufacturer of semiconductor equipment and thermal management solutions.
5+ YOEBachelor's in engineering or 5+ years equivalent experience; experience with supplier qualification, audits, root cause analysis, SPC, FMEA, and quality systems (ISO/AS9100).