Fluxus Inc. is seeking a highly motivated Senior Quality Engineer with broad experience in quality systems, product development and operations within the biotech industry. He/She will be part of an interdisciplinary team and will play a key role in the development, execution, and implementation of quality systems, supporting product development and transfer to manufacturing as well as production scale-up activities all related to a novel diagnostics platform.

Specific skills include:

• Leading product development teams in compliance related activities such as design control, design reviews, input/output matrices, specification development, biocompatibility, risk management, V+V, transfer to mfg.
• Development of standardized test methods, Gage R+Rs, DOEs, engineering and clinical builds.
• Develops plans for biocompatibility, transit testing, life testing and aging studies.
• Coordinates IQC activities, establishes sampling plans, generates NCRs, CAPAs.
• Oversees manufacturing QC testing and leads test method improvement activities.
• Maintains ASL, conducts vendor audits and provides feedback to suppliers.
• Coordinates and maintains oversight of the QMS system.
• Coordinates Internal Audits to maintain compliance to ISO 13485 and 21 CFR Part 820.
  
  

Responsibilities include but are not limited to the following:

• Quality representative for new product development
• Quality representative overseeing IQC and QC
• Will oversee ASL (approved supplier list)
• Will oversee the QSM (quality management system)
• Responsible for configuring and reviewing DOEs, protocols, process validations, performing data analysis, drawing conclusions, and communicating results.
• Support activities related to manufacturing
• Implementation and maintenance of the quality management system
  
  

Minimum Education And Experience Requirements

• BS degree with a minimum of 5 years of experience in medical device manufacturing and product development.
• Must have strong knowledge of medical device/IVD standards applicable to 21 CFR Part 820 and ISO13485 requirements.
• Superior time management, ability to work on several projects simultaneously, strong statistical skills.
• Excellent presentation and written/verbal communication skills.
• Experience working in a fast paced, small startup environment.
  
  

Other Beneficial Skill Sets

• Experience with QMS system using Greenlight Guru,
• Experience in Statistical Analysis/DOE using JMP, Minitab
• Lean-Six Sigma Black Belt
• Experience using Jira, NetSuite
• Experience training to ISO/QSR
  
  

About Fluxus

Fluxus is a leader in optofluidics that provides systems and solutions to advance the detection, diagnosis, monitoring, and treatment of disease. Our expertise lies in the interface of advanced photonics, MEMS, engineering, assay development, and reagent manufacturing excellence.

We seek to close a major gap in clinical research and diagnostics by bringing our groundbreaking ultrasensitive detection technologies and assay solutions to researchers, clinicians, patients, and key industry players through strong partnerships and a future-proof portfolio of innovative products.

Fluxus was founded in 2016 and acquired in 2022 by Fujirebio Holdings, Inc., an R&D-driven company developing novel IVD technologies and biomarkers with high clinical value.

Today, as a wholly owned subsidiary of Fujirebio, Fluxus represents a unique blend of Silicon Valley startup ingenuity with the stability and reach of an established multinational corporation. Our experienced, multidisciplinary team draws on deep and varied expertise to continuously innovate and drive towards our goal of becoming the gold standard in single molecule counting and ultrasensitive biomolecular testing.