Sr. Design Quality Engineer
Company: Genalyte, Inc.
Location: San Diego
Posted on: February 24, 2021
Since 2007, Genalyte has been guided by the vision of performing
panels of blood tests and receiving results within a few minutes.
As we look to the future, Genalyte's technology will transform
health care- moving lab testing from the lab into the physician's
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 seeking a Senior Design Quality Engineer to own all QA
design activities in support of our Maverick medical device
instrument. The Sr Design QE will support all the development,
implementation and continual improvement of the QMS and will work
closely with cross functional teams to support all QA activities
- Actively participate in product development and design transfer
activities for new and existing instrument and consumable
- Lead teams in execution of design control activities with a
focus on new product development, quality planning, and risk
management to positively impact the safety and efficacy of
- 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.
- Provide ongoing quality engineering support throughout the
product life cycle.
- 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 investigations and
corrective/preventive actions related to non-conformances
identified through CAPA, post market surveillance, customer
feedback, and provide product support as required to determine
deficiencies in the quality system, product, and manufacturing
- 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.
- Works independently or with cross-functional teams to lead and
support multiple projects, balancing priorities, and resources to
meet project and management expectations.
- Bachelor's degree or higher in a scientific field, 5+ years
related experience, preferably in medical devices, pharmaceutical,
or In Vitro diagnostics.
- Hands-on experience developing and implementing Corrective and
Preventive Actions (CAPA) plans, leading Failure Mode Effects
Analysis (FMEA), 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.
- Minimum of 5 years of experience leading internal audits and
representing organizations for certification and regulatory body
audits. ASQ Certified Quality Auditor certification is
- Significant experience and 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
- Experience leading cross-functional teams including, but not
limited to Complaint Handling Units, CAPA Review Boards, Risk
Analyses and Assessments, Root Cause and Failure Analyses, and
Material Review Boards.
- Strong verbal and written communication skills.
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Keywords: Genalyte, Inc., San Diego , Sr. Design Quality Engineer, Engineering , San Diego, California
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