Quality Engineer - Temp
Company: Genalyte
Location: San Diego
Posted on: February 14, 2026
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Job Description:
Job Description Job Description ABOUT GENALYTE At Genalyte,
we're revolutionizing diagnostic testing to empower a healthier
future. We believe that timely and accurate health insights
shouldn't be a luxury, but a necessity. We are driven by a vision
where advanced diagnostic capabilities are accessible, efficient,
and seamlessly integrated into healthcare. Genalyte is more than
just a laboratory; we are advocates for health empowerment,
dedicated to providing insights that can transform lives and
communities. POSITION SUMMARY The Quality Engineer will be a part
of the Quality Assurance team at Genalyte. This role will be
responsible for ensuring compliance with applicable regulatory
requirements and standards, maintaining quality system processes,
and supporting the development and manufacture of IVD products.
This is a temporary position. ESSENTIAL FUNCTIONS &
RESPONSIBILITIES These may include but are not limited to: Quality
Systems Management: Maintain and improve Quality Management System
(QMS) processes in compliance with ISO 13485, FDA 21 CFR Part 820,
and other relevant regulatory standards Conduct internal audits and
support external audits, including regulatory inspections Product
Development Support: Support product design team in the development
and release of product specifications and documentation Collaborate
with cross-functional teams to ensure design controls, risk
management, and product validations comply with regulatory and
quality requirements Participate with design teams in the
development of quality requirements, acceptance criteria and test
methods for components, assemblies and devices Participate in
design reviews and ensure proper documentation of design history
files (DHF) Support phase gate reviews for development projects at
scheduled intervals and ensure compliance to design control
regulations Prepare quality related deliverables per the design
control process Manufacturing Support: Work closely with product
teams to develop and approve manufacturing process documents
(procedures, work instructions) Develop manufacturing process
quality requirements and methods needed to support manufacturing
Prepare or support equipment qualification and process validation
protocols release, execution and reports Supplier Quality
Management: Working with Supply Chain and QA, qualify suppliers in
accordance with company processes and regulatory requirements
Evaluate and monitor supplier performance to ensure materials and
components meet specifications Perform acceptance activities for
supplied materials, as needed Compliance and Documentation: Ensure
proper documentation and traceability of quality records, including
complaints, deviations, and change controls Perform quality trend
analyses to demonstrate quality system effectiveness and compliance
Other tasks as assigned EDUCATION, EXPERIENCE, KNOWLEDGE, SKILLS
AND ABILITIES: A minimum of a Bachelor’s degree in Engineering,
Life Sciences, or a related field with 3 years of experience in
quality engineering within the medical device or IVD industry
Strong knowledge of ISO 13485 and FDA QSR Proficiency in quality
tools and methodologies, such as FMEA, SPC, and Root Cause Analysis
Experience with CAPA, nonconformance investigations, and risk
management Excellent problem-solving, analytical, and
organizational skills Strong communication and collaboration
abilities Preferred Qualifications: Certified Quality Engineer
(CQE) or equivalent certification Experience with statistical
analysis tools and software Familiarity with software quality
assurance for medical devices The base range for this role is
$39-$48 per hour. Individual pay may vary based on additional
factors, including but not limited to, job-related skills,
experience, work location, and relevant education or training.
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Keywords: Genalyte, Palm Springs , Quality Engineer - Temp, Science, Research & Development , San Diego, California
