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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 and reference job title.

Keywords: SCIEX, Lake Elsinore , Quality Engineering Lead , IT / Software / Systems , Brea, CA , California

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