29 quality systems specialist jobs at 23 companies in Bonsall, CA
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Specialist, Quality Systems
Tustin, California, United States
$32-$42/hrOnsiteFull Time
Avid Bioservices: Contract development and manufacturing organization for mammalian-derived biopharmaceutical products.
2+ YOEBachelor’s degree in life sciences or equivalent industry experience, 2–4 years of quality assurance experience, cGMP knowledge, quality standards interpretation, critical thinking, technical writing, and quality systems experience.
PCI Pharma Services: Integrated pharmaceutical development, manufacturing, and global packaging services.
1+ YOEHigh school diploma required; bachelor's in life sciences preferred. Requires 1–3+ years in quality systems, quality assurance, pharmaceutical manufacturing, biotechnology, or a regulated industry, plus GMP and QMS knowledge.
Werfen: Develops specialized diagnostic systems and reagents for clinical laboratories.
10+ YOEBachelor’s degree in life science or engineering required; 10+ years of quality systems/assurance experience and 8+ years in IVD or medical devices required. Advanced compliance, project management, audit, and cross-functional leadership skills required.
SAP, Gantt charts, Microsoft Word, Microsoft Excel, Microsoft Access, Microsoft Outlook, Microsoft PowerPoint, Microsoft Visio, Adobe Acrobat
Argonaut Manufacturing Services: Contract manufacturing organization for biopharmaceutical and diagnostic products.
4+ YOERequires 4+ years in pharmaceutical or biotech manufacturing focused on GMP investigations, strong root-cause analysis and technical writing skills, FDA and ICH knowledge, and excellent communication. Bachelor's degree strongly preferred.
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
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.
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.
(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
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)
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.
Clayton HomesNYSE: BRK.B: Builds and sells manufactured, modular, and site-built homes.
1+ YOERequires 1+ year of continuous improvement experience, process development and controlled documentation experience, lean and manufacturing systems knowledge, strong Excel and Microsoft Office proficiency, and strong communication skills. A four-year degree is highly desirable.
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
Pinnacle Claims Management: Third-party administrator for self-funded health benefit plans.
High school education or equivalent; distribution quality control experience preferred. Requires computer software, spreadsheet, ticketing system, organization, accuracy, customer service, and ability to lift 50 pounds.
Standard Operating Procedures (SOPs), distribution software, ticketing systems, spreadsheets
Western Growers: Trade association providing advocacy and insurance to agricultural businesses.
High school education or equivalent; one year of distribution quality control preferred. Requires computer software, ticketing system, spreadsheet, organizational, customer service, and document-sorting skills; ability to lift 50 pounds.