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Quality Control Supervisor

About us: Lucira Health is a startup striving to transform the way infectious diseases are diagnosed. Lucira Health is the first at-home COVID test authorized by the FDA. Our technology is a single-use, user-friendly COVID test kit that can produce a positive or negative result at home within 30 minutes. This technology bypasses centralized medical lab testing and streamlines patient care. Our current areas of focus include COVID and influenza.

 

 

Description:

As Quality Control Supervisor atLucira Health, Inc., your responsibility will be to ensure that materials and components meet Lucira requirements and are in accordance to regulations (CFR 820.30) and established standard operating procedures. Coordinate with Supply chain and manufacturing on prioritizing raw materials and components needed for evaluation. Ensure compliance to external & internal requirements and actively support and engage in Production meetings, Technical Reviews and Design reviews. Navigate various complex FDA regulations including ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and IEC 62366. Utilize problem solving methodologies including Six Sigma, Lean principles and Root cause analysis. 

 

 

Primary Job Function:

  • Primary point of contact for all quality control activities related to Incoming Quality Control, and decisions on prioritization of incoming activities to ensure continued compliance with internal procedures and applicable regulations.
  • Provides quality support to development, engineering and manufacturing functions for component and raw material inspection services.
  • Provides guidance on inspection, sample plan definition, and part approval plans.
  • Supports the quality deliverables (Incoming Quality Control). Reviews and thoroughly understands product functional and design specifications.
  • Coordinates with Manufacturing/Supply Chain on build plans and prioritization. Leader of Material Review Board (MRB) and responsible for ensuring IQC-related NCRs are closed in a timely manner.
  • Navigates various complex FDA regulations and ISO standards including ISO 13485, ISO 14971, IEC 60601-1, IEC 62304, and IEC 62366.
  • Utilizes problem solving methodologies including Six Sigma, Lean principles and Root cause analysis.
  • Understands sampling methods and techniques.  Support nonconformances and trending.  Support quality system activities including nonconforming material reports (NCMR), corrective and preventative actions (CAPA), internal and external audits.  
  • Performs and lead Gauge R&R and test method validation activities.
  • Collaborates with cross functional team to identify, prioritize and execute critical quality initiatives.

 

 

Qualifications:

  • Education: B.S. degree in Biomedical Engineering or Mechanical Engineering or related engineering discipline.
  • 7+ years of medical device experience in a quality/compliance role.
  • Experience in medical device, including software, reagents, and assay development, design control process.
  • Experience in representing the design/R&D team in multiple FDA Inspections.
  • Experience in molecular biology products or molecular diagnostic products or IVD
  • Experience of applying statistical analysis for testing, process control, and design of experiments.
  • Background: Engineering or Science background. Familiar with analysis.
  • Training: Familiar with the MS Office Suite. Good organizational, writing and verbal communication skills.
  • Lean principles, Sampling methods and Root cause analysis; CAPAs, NCMRs, complaint analysis and trending, and audits.
  • Process Failure Mode Analysis (PFMEA) and Design Failure Mode Analysis (DFMEA).
  • Hazardous substance regulations and Human factors & Usability Engineering.

 

Lucira Health is an Equal Opportunity Employer
Individuals seeking employment at Lucira Health are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation.

 

Job Category: Quality
Job Type: Full Time
Job Location: 1412 62nd St. Emeryville CA 94608

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