Quality Engineering Lead
Company: SCIEX
Location: Brea, CA
Posted on: August 16, 2019
Job Description:
Job Duties: 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 14971 standard • 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, Costa Mesa , Quality Engineering Lead , IT / Software / Systems , Brea, CA , California
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