Quality Engineering Lead
Location: Brea, CA
Posted on: August 16, 2019
Lead in the implementation of Design Controls and the CAPA system.
Provide QA oversight on non-product software
validation. Perform document review and approval of non-product
software validation documentation including
validation plan, protocols, and validation reports). Provide QA
oversight on software, hardware and consumable
development processes throughout the life-cycle of projects to
ensure adherence to procedures as required by QMS
including System Requirements Specifications, Design and
Development documentation, Verification and Validation
Test plans/procedures/final reports. Collaborate with the software
development team to ensure that verification and
validation activities are complete and robust. Perform document
review and approval of software, hardware, and
consumables engineering documentation. Review and maintain design
history files and ensure that they comply with
company procedures and regulatory requirements. Participate in
design reviews, design transfer activities, supplier
selection for new products and designs, and product risk reviews
during product development and post-launch
activities. Maintain product Risk Management files, and develop
quality plans, and assist internal audits and support
external audits. Perform review and approval of Engineering Change
Request and Engineering Change Orders, and will
oversee quality procedures and lead process definition and
improvement activities and training within the Product
Development group for the software, hardware, and consumable
functions, and participate in continuous improvement
activities in a cross-functional environment (e.g., Kaizen).
Utilize standard statistical techniques to determine product
acceptance, evaluate design capability and develop statistically
sound tolerance limits. Function as site technical
expert in CAPA/NCMR and complaint review/trending. Provide project
direction, coaching and mentoring for junior
Quality team members, engineering and technical team personnel.
Mentor for technical guidance for identifying and
resolving quality issues.
Education and Experience Requirements:
Bachelor's degree in Mechanical, Electrical, Chemical or Biological
Engineering or closely related field (foreign
education equivalent accepted) and eight (8) years of QA experience
within medical device industry.
Experience Must Include:
• ISO 13485, ISO 9001, FDA 21 CFR Part 820, medical devices, in
vitro diagnostic devices and familiarity with ISO
• Risk Management as it relates to Medical Devices products and
processes; and in the use and application of
quality tools, process improvement and info-mapping tools and
systematic problem-solving skills in identifying,
prioritizing, communicating, and resolving quality issues.
• Statistical analysis with statistical software packages
Qualified candidates please e-mail resume to
lisa.Hennigar@sciex.com and reference job title.
Keywords: SCIEX, Orange , Quality Engineering Lead , IT / Software / Systems , Brea, CA , California
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