Lucira Health
  • Emeryville, CA, USA
  • Full Time

About Lucira Health

Lucira Health is a medical technology company focused on the development and commercialization of transformative infectious disease test kits. We have developed a testing platform that produces centralized-laboratory-accurate molecular testing in a single-use and consumer-friendly test kit that is powered by two AA batteries and fits in the palm of a hand. Our LUCIRA Check It (OTC) and LUCIRA COVID-19 All-In-One Test Kit (Rx) are designed to provide a clinically relevant COVID-19 result within 30 minutes from sample collection.

Location

Emeryville, CA

Summary

As Senior Quality Engineer, you will be a leader in the development and execution of quality strategies and related activities and drive process improvement for sustaining manufacturing.

Responsibilities

  • Provides leadership in developing processes, methods, and criteria for inspections (in- process and final product).
  • Identifies and develops new quality metrics as needed
  • Identifies and resolves production and manufacturing problems or issues using quality tools and techniques such as root cause analysis, statistical analysis, and CAPA.
  • Lead investigation and disposition of nonconforming material.
  • Manage Equipment maintenance and calibration program.
  • Responsible for development and implementation of process inspection and test operations.
  • Responsible for driving continual quality and process improvements to assure processes are in a state of control.
  • Responsible for drafting and/or updating Quality procedures or work instructions
  • Initiates and reviews change orders and deviations.
  • Support development of sampling plans, test protocols, manufacturing floor process flows, work instructions, test methods, master validation plans, and performs any other quality related activities as assigned.
  • Determines conformance of products by following internal procedures and Quality System Regulation.
  • Regularly monitors product quality by gathering and maintaining manufacturing quality metrics

Qualifications

  • Experience in manufacturing/production and process control in a regulated industry (Medical Device) highly preferred.
  • Education: Bachelor's Degree in Engineering/Scientific Discipline
  • Experience: 6+ years of related work experience in a regulated (ISO 13485) industry
  • Good understanding of 21CFR part 820, part 11, ISO 9001, ISO 13485, and ISO 14971
  • Knowledge of product inspection standards, statistical sampling, statistical process control, measurement system analysis, advanced manufacturing, quality assurance, and pharmaceutical product development.
  • Ability to work independently and cross-functionally to provide effective updates at executive level
  • Detail oriented with well-developed organizational and analytical skills.
  • Experience working in a fast-paced, start-up environment is a plus.

Lucira Health is an equal opportunity employer and is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status or any other consideration made unlawful by federal, state or local law.


Lucira Health
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