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Manufacturing Jobs

Spec 3, Quality Assurance

Lancesoft

Irvine, CA

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JOB DETAILS
SALARY
$45
SKILLS
Analysis Skills, Change Requests/Orders, Code of Federal Regulations, Corrective Action, Data Analysis, Detail Oriented, Document Control, Documentation, FDA Requirements, ISO (International Organization for Standardization), Manufacturing, Medical Equipment, Microsoft Excel, Organizational Skills, Performance Analysis, Performance Metrics, Presentation/Verbal Skills, Problem Solving Skills, Process Improvement, Process Manufacturing, Procurement Management, Quality Assurance, Quality Management, Quality Metrics, Quality Monitoring, Quality System Requirements (QSR), Regulations, Regulatory Requirements, Risk, Time Management, Validation Testing, Vendor/Supplier Evaluation, Vendor/Supplier Management, Vendor/Supplier Quality Management
LOCATION
Irvine, CA
POSTED
16 days ago
Job Summary
Located in the vibrant city of Irvine, CA, this role offers the opportunity to work in a dynamic environment where innovation meets quality. The Supplier Quality Analyst is responsible for ensuring that suppliers of materials, components, and services used in medical devices consistently meet quality, regulatory, and risk requirements. This role supports compliance with FDA Quality System Regulation (21 CFR 820) and ISO 13485 through supplier performance monitoring, corrective action management, and risk-based supplier controls.
Key Responsibilities
  • Manage and maintain supplier qualification, monitoring, and re-evaluation activities in accordance with 21 CFR 820.50 (Purchasing Controls) and ISO 13485.
  • Monitor supplier quality performance using KPIs such as defect rates, corrective action trends, and supplier risk levels.
  • Maintain approved supplier lists (ASL) and supplier quality records per document control requirements.
  • Issue, track, and evaluate Supplier change requests.
  • Escalate supplier quality risks and support remediation and improvement plans.
  • Review and support supplier-initiated or internally driven changes that may impact product quality or compliance (materials, processes, manufacturing location).
  • Collaborate with Engineering and Regulatory Affairs to assess supplier changes requiring validation, verification, or regulatory impact evaluation.
  • Provide supplier quality input for management reviews and quality metrics.
  • Ensure supplier quality documentation is accurate, complete, and maintained in the electronic Quality Management System (eQMS).
  • Ensure supplier activities comply with internal procedures, regulatory requirements, and quality system expectations.
Required Qualifications
  • Bachelor’s degree in Engineering, Quality, or a related field;or equivalent experience.
  • 2–5 years of experience in Supplier Quality, Quality Assurance, or Manufacturing within a medical device or other regulated environment.
  • Working knowledge of 21 CFR 820, ISO 13485, and supplier control requirements.
  • Proficiency in Microsoft Excel and data analysis.
Key Skills & Competencies
  • Strong understanding of regulated quality systems
  • Analytical, detail-oriented problem-solving mindset
  • Clear written and verbal communication
  • Ability to influence suppliers and internal stakeholders
  • Strong organizational and time-management skills

About the Company

L

Lancesoft

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

COMPANY SIZE
2,000 to 2,499 employees
INDUSTRY
Staffing/Employment Agencies
FOUNDED
2000
WEBSITE
http://www.lancesoft.com/

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