Sr. Validation Quality Engineer
Company: Genalyte, Inc.
Location: San Diego
Posted on: January 16, 2022
Since 2007, Genalyte has been guided by a vision: to positively
impact human health by disrupting conventional diagnostic
techniques. Genalyte is disrupting the lab testing world by moving
lab testing from the research lab into the physician's office.
We are well funded with outstanding growth potential. We are
looking for individuals inspired by our technology and vision, who
are eager to be at the ground level of this collaborative and
We want to hire individuals who are interested in creating an
innovative, fast-paced and dynamic work setting. We offer a
competitive salary and benefits package to attract, motivate, and
retain the highest caliber of employee.
About the role:
We are looking for a Senior to staff level Quality Engineer to
support validation activities and the development, implementation,
and the continual improvement of the Quality Management System.
This position will work closely with cross functional teams to
support Quality Assurance (QA) activities and initiatives,
implement Quality Management System processes and procedures, and
provide guidance and support to site-wide validation
- Oversee validation projects and provide guidance at all stages,
from initial planning throughout execution, review, and
completion/approval of final reports.
- Partner with product validation teams to determine validation
strategies based on acceptable risk-based approach and support
sustaining validation activities.
- Provide oversight and guidance to equipment and process
validation team members during the development and execution of
manufacturing validation and qualification plans, protocols, and
- Partner with subject matter experts to identify and define
product specifications, sampling and testing requirements,
stability processes, and assisting with investigations of clinical
and commercial diagnostics and consumables manufactured by the
- Review and approve proposed design changes for products by
performing risk assessments, providing guidance and support, and
assessing the adequacy of verifications and validations.
- Lead and facilitate product and process risk management
activities including facilitating risk assessments and FMEA with
cross functional teams, maintaining risk management files, and
participating in risk analyses associated with design changes,
complaint handling, and failure analyses.
- Provide guidance and support to root cause, failure
investigations, and corrective/preventive actions related to
nonconformances identified through CAPA, post market surveillance,
customer feedback, and provide product support as required to
identify deficiencies in the quality system, product, and
- Provide quality oversight and guidance to medical device
software, diagnostic instrument, and consumable product realization
processes, ensuring adherence to company procedures and applicable
ISO 13485:2016 and FDA design control (820.30) requirements.
- Assists with supplier, certification body, and internal quality
system audits as a means of evaluating the effectiveness of the
established Quality System and Good Manufacturing Practices
implemented by the company.
- Bachelor's degree or higher in a scientific field, 5+ years
related experience, preferably in medical devices, pharmaceutical,
or In Vitro diagnostics.
- Extensive experience developing validation plans, protocols,
and reports and providing oversight and guidance to validation
- Hands-on experience developing and implementing Corrective and
Preventive Actions (CAPA) plans, leading root cause analysis (RCA),
implementing continual Improvement initiatives and well-versed in
problem-solving methodologies (Kaizen, Lean, Six Sigma, etc.).
- Working knowledge of statistical tools and methodologies used
to analyze data.
- Working knowledge of Quality System Regulations and
International Standards such as 21 CFR 11, 21 CFR 820, ISO 13485,
ISO 14971, EN 62366, EN62304 and In Vitro diagnostics
- Strong verbal and written communication skills.
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Keywords: Genalyte, Inc., San Diego , Sr. Validation Quality Engineer, Engineering , San Diego, California
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