Senior Quality Engineer - Software
Company: Fluxergy Inc
Posted on: September 24, 2022
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
Coaches teams on the application of FDA software devices and IEC
62304 requirements for product software lifecycle, verification,
Guides application software development and validation under
industry standards and regulations including 510k submissions, CFR
Interprets internal policies and procedures to ensure quality and
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
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
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
Keywords: Fluxergy Inc, Catalina Island , Senior Quality Engineer - Software, IT / Software / Systems , Irvine, California
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