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 Inc. is a development-stage medical device company located in Sunnyvale, CA, USA. The Company’s immediate focus is the development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics and bioanalytical applications. Our culture represents innovative, driven, and talented professionals with diverse perspectives, but one which is united on a mission to significantly and positively make a difference in healthcare.

As a member of Fluxus’ team, you would join an entrepreneurial and growing company that functions with the electricity of a startup but is led by a management team with a proven success record of 25+ years in life science tools and diagnostics. We look forward to hearing from you to learn more about your expertise and career goals. Fluxus provides a competitive benefits package and is an Equal Opportunity Employer regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.