31 quality systems specialist jobs at 24 companies in Fallbrook, CA
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Quality Systems Specialist
Aliso Viejo, California, United States
$85k-$100k/yrOnsiteFull Time
RxSightNASDAQ: RXST: Develops and manufactures adjustable intraocular lenses for cataract surgery.
2+ YOEManage equipment lifecycle, schedule calibrations/PMs, track events and maintain equipment records; knowledge of ISO 13485 and 21 CFR; bachelor\u0002s degree and 2 years relevant experience.
xTrak, Microsoft Word, Microsoft Excel, Smartsheet, Power BI
OrthofixNASDAQ: OFIX: Provides implants and stimulators for orthopedic and spinal surgeries.
3+ YOE3-5 years QA/QC experience in regulated medical device environment; expert knowledge of FDA QSR, ISO 13485/14971 and international standards; experience with electronic QMS, LMS and PLM systems and internal auditing.
OrthAlign: Handheld navigation systems for precise orthopedic joint surgery.
1+ YOERequires 1+ year in medical device quality or operations, MS Office proficiency, familiarity with ISO 13485 and 21 CFR 820, electronic quality and document systems, root cause analysis, communication, and organizational skills.
Microsoft Word, Microsoft Excel, Microsoft Outlook, QCBD, EtQ, Oracle Agile, Documentum, PLM
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
2+ YOEBachelor's in a scientific field,2+ years QA/QC experience in regulated industry (RUO preferred),knowledge of QMS,change management,CAPA,root-cause analysis,data analysis,organizational and communication skills.
Quality Specialist, Intelligence Systems (Second Shift)
Santa Ana, California, United States
$41-$55/hrOnsiteFull Time
Anduril Industries: Defense technology building autonomous military hardware and software.
3+ YOE3+ years metrology/quality inspection experience, associate degree or equivalent, proficiency with ERP/MES and inspection tools, GD&T knowledge, ability to maintain active U.S. Secret clearance.
Bio-Rad LaboratoriesNYSE: BIO: Global provider of life science and clinical diagnostic products.
3+ YOEBachelor’s degree in a relevant science or engineering field; 3–5 years of regulated quality systems experience; 2 years with ERP systems; QMS, audit, leadership, and continuous improvement skills.
Quality Management System (QMS), Enterprise Resource Planning (ERP), SAP, Oracle, Microsoft Word, Microsoft Excel
Pacific Health Group: Integrated healthcare and social support for vulnerable California communities.
2+ YOEBachelor's degree required, 2+ years QA/care coordination or compliance experience, familiarity with CalAIM/Medi-Cal/HIPAA, proficiency with CRM/EMR systems and Excel, strong analytical and communication skills, driver's license and reliable transportation for outreach.
B. Braun: Develops and manufactures medical devices and pharmaceutical products globally.
6+ YOEBachelor's degree or equivalent, 6+ years in a regulated industry, strong quality systems and data integrity knowledge, ability to review documentation and support investigations, excellent problem-solving and communication skills.
Avid Bioservices: Contract development and manufacturing organization for mammalian-derived biopharmaceutical products.
1+ YOEBA/BS preferred (life science),1+ year biopharma experience, knowledge of cGMPs, document control and training systems, ability to support inspections and work overtime/weekends.
(Senior) Quality Specialist for Distributed Systems (Riverside, CA, US)
Riverside, California, United States
OnsiteFull Time
SAPFrankfurt Stock Exchange: SAP: Developer of enterprise business software and cloud applications.
Experience with distributed systems, system administration on Linux, proficiency in two of Java/C++/Python, BS/MS in CS or Electrical Engineering, strong architecture and cloud platform knowledge.
Viking TherapeuticsNASDAQ: VKTX: Develops therapies for metabolic and endocrine disorders.
3+ YOE3+ years QA experience in a GMP environment; experience implementing Veeva Vault/Basics, knowledge of GxP and 21 CFR Part 11, strong communication and process-mapping skills.
Veeva Vault, Veeva Basics, Veeva Vault Quality Suite
Continuous Improvement Specialist I - Fluid Systems Division
Irvine, California, United States
$100k-$159k/yrOnsiteFull Time
Parker HannifinNYSE: PH: Manufacturer of motion and control technologies and systems.
6+ YOEBachelor's in engineering or manufacturing, 6+ years applying continuous improvement/lean principles in production, strong analytical and training skills, knowledge of quality and project management, familiarity with FAA/ATA/regulatory standards preferred.
Abzena: Provides contract development and manufacturing for complex biopharmaceuticals.
4+ YOEB.S. in Life Sciences or Engineering and 4+ years GMP biopharmaceutical experience; proficiency in batch record review, quality systems, GMP/21CFR, lean methodologies, and cross-functional collaboration.
Lighteum Medical: Manufactures high-precision metal components for minimally invasive medical devices.
2+ YOEHigh school diploma or equivalent, 2+ years of document control or quality systems experience in regulated manufacturing, ISO 13485 experience, eQMS experience, and strong written and verbal skills.
MasterControl, Electronic Quality Management System (eQMS)
TS Conductor: Manufacturing advanced conductors to modernize global electricity transmission grids
1+ YOE1–5 years quality/document control experience, knowledge of ISO 9001:2015, experience with document control systems, strong communication, attention to detail, and proficiency with Microsoft Windows/MAC and Microsoft Office.
Cordis: Develops and manufactures cardiovascular and endovascular medical devices.
Provide document and change control support, maintain controlled records, support audits, train PLM users; familiarity with document control systems and quality regulations required.
Product Lifecycle Management (PLM), Microsoft Word, Microsoft Excel, Microsoft Outlook
TriLink BioTechnologiesNASDAQ: MRVI: Manufactures modified nucleic acids and mRNA reagents for biotechnology.
5+ YOEBachelor's in a scientific discipline, 5+ years QA experience in life sciences, knowledge of ISO 9001/13485, experience with quality systems, strong communication and problem-solving, proficient in Microsoft Office.
JenaValve Technology: Developing transcatheter heart valve systems for aortic disease treatment.
3+ YOE3–5 years medical device regulatory affairs experience, bachelor’s in a scientific discipline, knowledge of global medical device regulations and quality systems, strong writing and communication skills, and ability to manage submissions and adverse event reporting.
Cordis: Developer of interventional cardiovascular and endovascular medical devices.
0+ YOEBachelor's degree or equivalent; experience with document/PLM systems; proficiency in Microsoft Word/Excel/Outlook; knowledge of ISO 13485 and FDA 21 CFR Part 820; strong attention to detail and communication skills.
Product Lifecycle Management (PLM), Microsoft Word, Microsoft Excel, Microsoft Outlook