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Senior Quality Engineer - Software

Company: Fluxergy Inc
Location: Irvine
Posted on: September 24, 2022

Job Description:

Fluxergy is a rapidly growing biomedical company on the cutting edge of laboratory testing. We're developing a true multi-modal point of care device, the kind of which has never been conceived, and we'd love to have you as part of the team. Fluxergy's technologies span many markets in addition to healthcare, including veterinary, food safety, and wellness industries. We are seeking motivated team members who are willing to commit themselves and their time to improving and decentralizing laboratory infrastructure to the places that need it most. With its roots in engineering, Fluxergy prides itself on critical thinking and solving problems pragmatically, from a modular and systems-level approach. We believe that open and clear communication along with the ability to adapt to changing situations and working outside of your comfort zone is paramount to our success. The ideal candidate for this position should embody these philosophies as well as be resourceful, trustworthy, and have a deep desire to constantly learn. The Senior Quality Assurance Engineer will represent quality assurance on development core teams, current business project teams or product improvement projects for Fluxergy. Products supported include laboratory automation, flow cytometry, PCR, and particle counting. Ideal candidates will possess an understanding of quality systems, design controls, industry standards, and lifecycle processes for hardware and software including embedded, product, and cloud environments. Responsibilities Assure process conformance and complete product documentation, including design history and process documentation, that supports compliant standard and custom product realization within the Fluxergy quality system.
Partners with engineering teams to ensure product and service compliance to ISO 9001, ISO 13485, and/or 21 CFR 820 standards with a particular focus on design controls, document controls, risk management, production, service controls, and product privacy and security.
Coaches teams on the application of FDA software devices and IEC 62304 requirements for product software lifecycle, verification, and validation.
Guides application software development and validation under industry standards and regulations including 510k submissions, CFR Part 11.
Interprets internal policies and procedures to ensure quality and compliance.
Drives cross-functional changes by identifying, developing, and executing quality system, product, and process improvements.
Develop software/firmware quality assurance strategy to determine software/firmware quality and release readiness.
Develop and maintain automated infrastructure and tooling with cloud technologies and embedded devices.
Create and evolve continuous integration systems and strategies.
Create and run automated regression test suites.
Drive functional level tests from a product platform perspective and specify required test vectors.
Create and maintain high-quality documentation, including documentation of test plans and procedures, test case specifications, and detailed test reports.
Identify, isolate, reproduce, and track bugs and their resolutions.
Working knowledge of regulatory requirements for ISO 9001, ISO 13485, IEC 62304 and/or 21 CFR 820, CFR part 11 standards.
Understanding of current industry standards and regulations as they relate to internal policies and procedures.
Certified Software or Quality Engineer (SQA) preferred and/or Auditor Certification desired but not necessary Experience 5+ years of experience in product development, manufacturing, and/or quality in the medical device, pharmaceutical, or related regulated fields (e.g FDA, DoD, Aerospace, Automotive). Education Minimum - Bachelor's Degree in computer science, Electrical Engineering, Computer Engineering, Aerospace Engineering, or related fields.
Preferred - Masters' Degree in Computer Science, Electrical Engineering, Computer Engineering, Aerospace Engineering or related fields.

Keywords: Fluxergy Inc, Malibu , Senior Quality Engineer - Software, IT / Software / Systems , Irvine, California

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